← Product Code [FDS](/productcode/FDS) · K261400

# Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (K261400)

_Ambu A/S · FDS · Sep 16, 2026 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K261400

## Device Facts

- **Applicant:** Ambu A/S
- **Product Code:** [FDS](/productcode/FDS.md)
- **Decision Date:** Sep 16, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

The device is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy. The endoscope is also intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy, specifically the rectum and the sigmoid colon. The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.

## Device Story

Sterile, single-use, flexible endoscope for upper and lower GI tract examination; provides visualization via compatible Ambu aBox 2 displaying unit. Input: optical images from distal tip camera. Transformation: image signal processing via connected displaying unit. Output: real-time video visualization on monitor. Operation: physician-controlled via handle wheels for tip bending and valves for insufflation, suction, and rinsing. Includes programmable buttons for displaying unit functions. Benefits: single-use design eliminates reprocessing requirements, reducing cross-contamination risk. Used in clinical settings for diagnostic and therapeutic procedures.

## Clinical Evidence

Bench testing only. Verification tests included geometric measurements, tip bending angles, and performance of insufflation, suction, and rinsing. Optical performance validated per ISO 8600-3 (field of view, sharpness, depth of field, distortion, intensity, color, noise, dynamic range). Safety testing included photobiological safety (IEC 62471), biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-18), and electromagnetic compatibility (IEC 60601-1-2). Packaging, sterilization (ISO 11135), and shelf-life stability were also validated. All tests met predefined acceptance criteria.

## Technological Characteristics

Flexible endoscope with distal camera, bending section, and working channel. Materials validated for biocompatibility per ISO 10993-1. Powered by connection to Ambu aBox 2 displaying unit. Connectivity: proprietary connector to displaying unit. Sterilization: ethylene oxide (ISO 11135). Standards: ISO 8600-3 (optics), IEC 60601-1/2-18 (electrical safety), IEC 60601-1-2 (EMC), ASTM D4169 (transportation).

## Regulatory Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

## Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:

1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
   1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
   2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
   3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

## Predicate Devices

- Endoscope Model EI-740D/S ([K210162](/device/K210162.md))
- Ambu® aScope™ Gastro ([K212382](/device/K212382.md))
- Ambu® aScope™ Gastro Large ([K232919](/device/K232919.md))
- Ambu® aScope™ Colon ([K230332](/device/K230332.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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FDA U.S. FOOD & DRUG ADMINISTRATION

September 16, 2026

Ambu A/S
% Sanjay Parikh
Senior Director, QA/RA
Ambu, Inc.
6721 Columbia Gateway Dr., Suite 200
Columbia, Maryland 21046

Re: K261400

Trade/Device Name: Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large

Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope And Accessories

Regulatory Class: Class II

Product Code: FDS, FAM

Dated: August 14, 2026

Received: August 14, 2026

Dear Sanjay Parikh:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261400 - Sanjay Parikh

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K261400 - Sanjay Parikh

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

SIVAKAMI VENKATACHALAM -S

*for*

Shanil P. Haugen, PhD

Assistant Director

DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices

OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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K261400

|  Indications for Use  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261400 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  Ambu® aScope™ Gastro;Ambu® aScope™ Gastro Large  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  The device is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.The endoscope is also intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy, specifically the rectum and the sigmoid colon.The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.  |   |   |
|  Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |

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K261400, Page 1 of 3

|  510(k) #: K261400 | 510(k) Summary | Prepared on: 2026-08-14  |
| --- | --- | --- |
|  Contact Details |  | 21 CFR 807.92(a)(1)  |

|  Applicant Name | Ambu A/S  |
| --- | --- |
|  Applicant Address | Baltorpbakken 13 Ballerup 2750 Denmark  |
|  Applicant Contact Telephone | +4982332189113  |
|  Applicant Contact | Ms. Martina Krautwald  |
|  Applicant Contact Email | maka@ambu.com  |
|  Correspondent Name | Ambu Inc.  |
|  Correspondent Address | 6721 Columbia Gateway Drive, Suite 200 Columbia MD 21046 United States  |
|  Correspondent Contact Telephone | +1 443 831 9844  |
|  Correspondent Contact | Mr. Sanjay Parikh  |
|  Correspondent Contact Email | sap@ambu.com  |

|  Device Name | 21 CFR 807.92(a)(2)  |
| --- | --- |
|  Device Trade Name | Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large  |
|  Common Name | Endoscope and accessories  |
|  Classification Name | Gastroscope And Accessories, Flexible/Rigid  |
|  Regulation Number | 876.1500  |
|  Product Code(s) | FDS, FAM  |

|  Legally Marketed Predicate Devices |   | 21 CFR 807.92(a)(3)  |
| --- | --- | --- |
|  Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code  |
|  K210162 | Endoscope Model EI-740D/S | FDS  |
|  K212382 | Ambu® aScope™ Gastro | FDS  |
|  K232919 | Ambu® aScope™ Gastro Large | FDS  |
|  K230332 | Ambu® aScope™ Colon | FDF  |

|  Device Description Summary | 21 CFR 807.92(a)(4)  |
| --- | --- |
|  The Ambu® aScope™ Gastro and the Ambu® aScope™ Gastro Large are sterile and single-use endoscopes for use in the upper gastrointestinal (GI) tract, and the lower GI tract, specifically the rectum and sigmoid colon.  |   |

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K261400, Page 2 of 3

The endoscopes consist of a flexible insertion tube with bending section and distal end, a control section and an umbilical cord with endoscope connector. The working channel allows for the passage of endotherapy accessories, instillation of fluids, and suction of fluids. The auxiliary water system allows the instillation of fluids. The insufflation/rinsing fluid management system allows the instillation of CO₂ to expand the GI lumen and rinsing of the lens. Insufflation, suction and rinsing functions are activated by the respective valves, and the bending of the endoscope tip is controlled via wheels at the control section.

The endoscopes are powered by connection to the displaying unit, Ambu® aBox™ 2, via the endoscope connector. The endoscopes contain remote switches / programmable buttons to activate selected functions of the connected displaying unit.

## Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The device is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.

The endoscope is also intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy, specifically the rectum and the sigmoid colon.

The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.

## Indications for Use Comparison

21 CFR 807.92(a)(5)

Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large have the same indications for use as the predicate device, Endoscope Model EI-740D/S.

## Technological Comparison

21 CFR 807.92(a)(6)

Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large and their predicate device have the following same technological characteristics:

- All devices control the maneuverable distal end by moving the wheels at the handle.
- All devices have valves at the handle to activate insufflation, suction and rinsing functions.
- All devices have at least one working channel with one inlet and outlet.
- All devices have a camera at the distal tip of the insertion cord.
- All devices are designed to connect to a compatible monitor.

Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large differ from their predicate device in some technical specifications, including the number of working channels and the insertion portion diameter. Furthermore, the Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large are single-use devices whereas the predicate device is reusable. In addition, the camera technology of Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large differs from that of the predicate device, however, the applicant devices have the same camera module and image pipeline as the reference device which was used to support the image performance testing. It is concluded, that the differences do not introduce issues for safety and performance. Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large have passed the performance testing. Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large are substantially equivalent to the predicate device in terms of safety and performance.

## Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

The following tests were performed to verify/validate the design and evaluate the performance of the Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large.

Verification tests including:

- Measurement of the geometric characteristics of the endoscopes, such as minimum instrument channel width, length of insertion portion and outer diameter of the bending section.
- Tip reach and bending angles
- Insufflation, Suction, Rinsing and Water Jet performance

Optical performance tests including:

- Field of view (ISO 8600-3)
- Direction of view (ISO 8600-3)
- Sharpness and Depth of field
- Geometric distortion
- Image intensity uniformity
- Color performance

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K261400, Page 3 of 3

- Noise characterisation
- Dynamic range

Photobiological safety according to IEC 62471

Transportation study according to ASTM D4169

Sterilization validation according to ISO 11135

Stability study to document shelf-life

Sterile packaging integrity

Biocompatibility according to ISO 10993-1 including tests for:

- Physical and/or chemical information
- Cytotoxicity
- Irritation
- Sensitization

Electrical Safety and performance according to IEC 60601-1 and IEC 50601-2-18

Electromagnetic Compatibility according to IEC 60601-1-2

In all instances, the Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large performed as expected and met the test specifications set.

N/A

All included bench tests, that have been designed to evaluate substantial equivalence as well as the products' conformity to established quality and performance measures, have been conducted successfully, have been documented, and have passed the predefined acceptance criteria.

As a result, it is concluded that the Ambu® aScope™ Gastro and Ambu® aScope™ Gastro Large meet the predefined specifications, perform as intended and are equivalent to the predicate/reference devices listed in the Predicates and Substantial Equivalence section.

---

**Source:** [https://fda-staging.innolitics.com/device/K261400](https://fda-staging.innolitics.com/device/K261400)

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