← Product Code [FGB](/productcode/FGB) · K262552 # Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) (K262552) _Scivita Medical Technology Co., Ltd. · FGB · Aug 14, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K262552 ## Device Facts - **Applicant:** Scivita Medical Technology Co., Ltd. - **Product Code:** [FGB](/productcode/FGB.md) - **Decision Date:** Aug 14, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. ## Device Story Single-use flexible ureteroscope; used with endoscopic image processor; provides visualization of urinary tract (urethra, bladder, ureter, renal pelvis) on video monitor. Device features single working channel for irrigation; distal end deflection controlled by two traction wires in operation section. Operated by clinicians in clinical settings for diagnostic and therapeutic procedures. SUV-5C-B model modifies deflection direction relative to predicate SUV-2C-B to accommodate different operator handling preferences. Device is single-use; sterile; provides real-time visual feedback to assist physician in navigating urinary anatomy and performing interventions. ## Clinical Evidence No clinical data. Bench testing only. Compliance verified via ISO 8600-1:2025 (surface/edges, deflection angle), ISO 8600-3:2019 (field/direction of view), and ISO 8600-4:2023 (insertion width). Electrical safety and EMC testing performed per IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2. ## Technological Characteristics Single-use flexible ureteroscope; 2.5mm insertion width; 680mm working length. Materials: Glass, Sulfone polymer, 304 SUS, Pebax, PET, PA12, PC, Silicone rubber. Single working channel. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Connects to endoscopic image processor. Deflection: Two-wire traction system. ## 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 - Single-use Flexible Ureteroscope ([K243708](/device/K243708.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. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION August 14, 2026 Scivita Medical Technology Co., Ltd. Mengxuan Yuan Senior Regulatory Specialist # 2, Qingqiu St., Suzhou Industrial Park Suzhou, Jiangsu Prov. 215000 CHINA Re: K262552 Trade/Device Name: Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: July 23, 2026 Received: July 24, 2026 Dear Mengxuan Yuan: 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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (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 {1} K262552 - Mengxuan Yuan Page 2 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 {2} K262552 - Mengxuan Yuan Page 3 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-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, Mark R. Kreitz -S for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | 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. | K262552 | ? | | Please provide the device trade name(s). | | ? | | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | | | | Please provide your Indications for Use below. | | ? | | Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. | | | | 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) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K262552 Page 1 of 2 | 510(k) #: 510(k) Summary Prepared on: 2026-08-12 | | | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | Scivita Medical Technology Co.,Ltd. | | | Applicant Address | No. 2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov. , P.R.CHINA Suzhou 215000 China | | | Applicant Contact Telephone | 86-512-81877788 | | | Applicant Contact | Mrs. Wu Ruqin | | | Applicant Contact Email | wuruqin@scivitamedical.com | | | Correspondent Name | Scivita Medical Technology Co.,Ltd. | | | Correspondent Address | No. 2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov. , P.R.CHINA Suzhou 215000 China | | | Correspondent Contact Telephone | 86-512-81877788 | | | Correspondent Contact | Mr. Mengxuan Yuan | | | Correspondent Contact Email | ra@scivitamedical.com | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | | | Common Name | Endoscope and accessories | | | Classification Name | Ureteroscope And Accessories, Flexible/Rigid | | | Regulation Number | 876.1500 | | | Product Code(s) | FGB | | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K243708 | Single-use Flexible Ureteroscope | FGB | | Device Description Summary | | 21 CFR 807.92(a)(4) | | The subject device, Single-use Flexible Ureteroscope is single use devices. It is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There is one model of Single-use Flexible Ureteroscope, with insertion portion widths (2.5mm), working lengths (680mm), material used Glass, Sulfone polymer, 304 SUS, Pebax, PET, PA12, PC, Silicone rubber. The Single-use Flexible Ureteroscope is single-channel endoscope. Only one working channel is in the distal end of the endoscope and | | | {5} K262552 Page 2 of 2 | lead to the irrigation valve. | | | --- | --- | | The Single-use Flexible Ureteroscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years. | | | Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | | Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. | | | Indications for Use Comparison | 21 CFR 807.92(a)(5) | | The indications for use of the subject device is the same as predicate device. Both the subject device and predicate device are used for endoscopic diagnosis and therapies within the urinary system. | | | Technological Comparison | 21 CFR 807.92(a)(6) | | The subject device has the same technical characteristics as the predicate device. They have the same specifications, designed structure and materials. This submission is intended to create a new model Single-use Flexible Ureteroscope SUV-5C-B by deflection direction modification of the existing device Single-use Flexible Ureteroscope model SUV-2C-B (K243708) for market needs to adapt to the operators' different operating habit when holding the Single-use Flexible Ureteroscope. The endoscope has two traction wires in operation section used to adjust distal end's deflection direction. Compared with SUV-2C-B, SUV-5C-B transposes install these two traction wires to achieve opposite deflection direction to SUV-2C-B. The only differences between model SUV-5C-B and SUV-2C-B are the different deflection directions, and the indications for use, material, specifications and processes are the same. | | | Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b) | | The only differences between proposed new model Single-use Flexible Ureteroscope SUV-5C-B and the predicate Device Single-use Flexible Ureteroscope SUV-2C-B are the different deflection directions. Different deflection directions may affect deflection angle, the manufacture conduct ISO 8600-1 test for deflection angle verification. The subject device was designed to comply with applicable parts of ISO 8600-1:2025 (surface and edges, Angle of deflection Test), ISO 8600-3:2019 (Field of View and Direction of View), ISO 8600-4:2023 (Maximum insertion portion width). Also, regarding EMC and electrical safety testing, manufacture refreshed IEC60601-1, IEC60601-2-18 and IEC 60601-1-2 test report of Single-use Flexible Ureteroscope SUV-2C-B to cover this new model SUV-5C-B and applied NRTL certificate by OSHA recognized NRTL. The clinical data is not applicable. The non-clinical test were conducted to demonstrate that the subject is as safe and effective as the predicate. All other relevant testing was leveraged from the predicate submission (K243708). | | --- **Source:** [https://fda-staging.innolitics.com/device/K262552](https://fda-staging.innolitics.com/device/K262552) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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