← Product Code [HIH](/productcode/HIH) · K260984 # HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) (K260984) _Axora Medical, Inc. · HIH · Aug 18, 2026 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K260984 ## Device Facts - **Applicant:** Axora Medical, Inc. - **Product Code:** [HIH](/productcode/HIH.md) - **Decision Date:** Aug 18, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1690 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for Use The HERizon RD5™ Resecting Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue such as endometrial polyps. ## Device Story Battery-powered, motor-driven, manually-actuated hysteroscopic surgical instrument; used in OR, surgical centers, or physician offices. Input: manual activation via button. Transformation: motor spins internal stainless steel blade within distal cannula window; blade oscillates radially; mechanical valve opens to enable suction. Output: resected tissue evacuated through device to external suction source/tissue catch. Benefit: enables minimally invasive removal of intrauterine tissue under direct visualization. Physician-operated; provides mechanical resection of polyps. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11135), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and mechanical/functional performance (cutting performance, torque, tensile strength, vacuum maintenance) at baseline and after 1-year accelerated aging. ## Technological Characteristics Battery-powered (up to 6V); 5Fr (1.65 mm) outer diameter; 36.3 cm cannula length. Materials: stainless steel (distal patient-contacting components), molded plastics (handle). Sensing/Actuation: motor-driven radial blade oscillation. Connectivity: standard luer/stepped connectors for fluid management/suction. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993, ISO 11135, IEC 60601-1, IEC 60601-1-2, ASTM D4169, ASTM F1980. ## Regulatory Identification A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts. ## Predicate Devices - BenestaTM Tissue Removal ([K233500](/device/K233500.md)) - ResectrTM Device ([K191538](/device/K191538.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} FDA U.S. FOOD & DRUG ADMINISTRATION August 18, 2026 Axora Medical, Inc. % Natalie J. Kennel Regulatory Affairs Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 Re: K260984 Trade/Device Name: HERizon RD5™ Resecting Device Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: July 22, 2026 Received: July 23, 2026 Dear Natalie J. Kennel: 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 {1} K260984 - Natalie J. Kennel 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. {2} K260984 - Natalie J. Kennel Page 3 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-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, # Reginald K. Avery -S for Jason R. Roberts, Ph.D. 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. | K260984 | ? | | Please provide the device trade name(s). | | ? | | HERizon RD5™ Resecting Device | | | | Please provide your Indications for Use below. | | ? | | The HERizon RD5™ Resecting Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue such as endometrial polyps. | | | | 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} AXORA MEDICAL K260984 Page 1 of 7 # 510(k) Summary Sponsor: Axora Medical Inc. 1 Independent Drive Jacksonville, FL 32202 Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 Email: NKennel@njkconsulting.com Date Prepared: August 16, 2026 ## DEVICE INFORMATION: Proprietary Name: HERizon RD5™ Resecting Device Regulation Name: Hysteroscope and accessories Classification: Class II Product Codes: HIH Regulations: 21 CFR 884.1690 Classification Panel: Obstetrics/Gynecology ## PREDICATE DEVICES: Table 1 contains information about the predicate devices: Table 1 Predicate Device Information | 510(k)# | Product Name | Sponsor /510(k) holder | Clearance Date | Role | | --- | --- | --- | --- | --- | | K233500 | BenestaTM Tissue Removal | Caldera Medical | Nov. 30, 2023 | Primary predicate | | K191538 | ResectrTM Device | Boston Scientific/Minerva Surgical/Axora Medical\( ^{1} \) | Jan.16, 2020 | Secondary predicate | None of the predicate devices have been the subject of a design related recall. \( ^{1} \) Boston Scientific Corporation obtained the clearance and later sold this clearance to Minerva Surgical. Axora Medical acquired this asset from Minerva on Jan. 30, 2026 HERizon RD5™ Resecting Device Page 1 of 7 {5} K260984 Page 2 of 7 # PRODUCT DESCRIPTION: The HERizon RD5™ Resecting Device is a battery powered, motor driven, and manually actuated hysteroscopic surgical instrument used to resect and remove tissue under direct visualization. The device is supplied sterile for single use only. The device is offered in a 5Fr size for compatibility with hysteroscopes that can accommodate instruments with a 1.65 mm outer diameter or larger. The device can be used with any fluid management system made with standard luer and/or stepped connectors. The HERizon RD5™ device consists of a distal and proximal section. The distal section is comprised of an outer cannula with an open Resecting Window at the distal end, and a cutting element that rotates within the lumen of the outer cannula to resect tissue within the Resecting Window. The proximal section, made of molded plastics, is comprised of a cylindrically shaped handle with an Activation Button. Depressing the Activation Button actuates a motor that spins a blade within the Resecting Window to resect and remove target tissue. Depressing the Activation Button also opens a mechanical valve within the handle body. When open, evacuation of resected tissue is enabled. The devices are provided assembled with a vacuum tube port for use with a suction source. As tissue is resected, it is evacuated through the length of the device and out the vacuum tube port. The distal section, the patient contacting portion, including the cannula and cutting element are made of stainless steel. # INDICATIONS FOR USE: The HERizon RD5™ Resecting Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue such as endometrial polyps. # SUBSTANTIAL EQUIVALENCE Table 2 contains the substantial equivalence table comparing the HERizon RD5™ Resecting Device to its predicates. The table shows that the subject device has the same intended use as both predicates. The subject device uses similar design and technology as one or both of the predicates. The subject device is battery powered, same as its primary predicate device. The subject device is a single use disposable device provided sterile, same as both predicates. The subject device has similar dimensions and compatibility as at least one model of both predicates. The subject device is made of the same type of materials as both predicates. The subject device has some minor differences in the way the resection is activated in the predicates but the differences do not raise different issues of safety and effectiveness. The HERizon RD5™ Resecting Device has the same intended use and similar technology characteristics as compared to its primary and secondary predicate devices. The difference between the subject device and predicate devices do not raise different questions of safety or effectiveness. HERizon RD5™ Resecting Device Page 2 of 7 {6} K260984^{}[] Page 3 of 7 **Table 2 Substantial Equivalence Table Comparing HERizon RD5™ Resecting Device to its Predicates** | Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Comparison | | --- | --- | --- | --- | --- | | Trade Name | HERizon RD5™ Resecting Device | Benesta® Tissue Removal Device | Resectr™ Tissue Resection Device | NA | | 510(k) | New | K233500 | K191538 | NA | | Submitter/ 510(k) Holder | Axora Medical Inc. | Caldera Medical Inc. | Minerva Surgical/Axora Medical^{2} | NA | | Device type | Hysteroscope and accessories | Hysteroscope and accessories | Hysteroscope and accessories | Same | | Classification | Class II | Class II | Class II | Same | | Regulation | 884.1690 | 884.1690 | 884.1690 | Same | | Product code | HIH | HIH | HIH | Same | | Indications for Use | The *HERizon RD5™* Resecting Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue such as: endometrial polyps | The Caldera Medical Benesta™ Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception. | The Resectr™ Tissue Resection Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue, including focal lesions such as endometrial polyps. | Same intended use to resect and remove intrauterine tissue. The indications included are in both primary and secondary predicate | | Usage | Single use disposable | Single use disposable | Single use disposable | Same | | Use Environment | operating room, surgical center and physician's office environments where surgical procedures are performed | operating room, surgical center and physician's office environments where surgical procedures are performed | operating room, surgical center and physician's office environments where surgical procedures are performed | Same | | Power source/ Operating voltage | Battery/ Up to 6 V | Battery/ 7.7 - 9.0 V | Manual | Primary predicate is battery powered with similar voltage. Slight difference in voltage does not raise different issues of safety or effectiveness. | $^{2}$ Boston Scientific Corporation obtained the clearance and later sold this clearance to Minerva Surgical. Axora Medical acquired this asset from Minerva on Jan. 30, 2026. HERizon RD5™ Resecting Device Page 3 of 7 {7} K260984^{}[] Page 4 of 7 | Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Comparison | | --- | --- | --- | --- | --- | | Sterilization | Provided sterile- Ethylene oxide | Provided sterile- Ethylene oxide | Provided sterile- Ethylene oxide | Same | | Outer diameter | 5F (1.65 mm) | Benesta OD 4.0 mm (12F) | 5F (1.65 mm) and 9F (3.0mm) | Subject device same as one of two Resectr™ predicate device models (5F) | | Cannula length | 36.3 cm | 35 cm | 35.3 cm | Subject device similar to both predicates | | Resecting Window length | 5.0 mm | 15.0 mm | 5.0 mm (5 F) | Subject device same as Resectr™ predicate | | Directionality of resecting blade | Resecting blade oscillates radially relative to the cannula | Resecting blade translates axially along the cannula length. During translation, resecting blade rotates | Resecting blade oscillates radially relative to the cannula | Subject device same as Resectr™ predicate | | Resecting Window orientation | Side facing window | Side facing window | Side facing window | Same | | Resecting Window orientation indicator | Laser markings | Laser markings | Laser markings | Same | | Blade actuation | Upon pressing a button, a motor is activated that rotates the resection blade. The resection blade rotates three times in one direction before changing directions and rotating three times in the opposite direction. | Blade is actuated using a momentary switch to activate the motor. An additional sliding switch sets the on/off state of the device which connects or disconnects the internal battery to the rest of the internal electronics. | Each handle squeeze and release on the Resectr™ device rotates the blade bi-directionally for a total of six resection actions across the cannula window. | Subject device is similar to the predicate devices. Primary predicate blade is actuated with a switch or motor like subject device. Secondary predicate is actuated with manual squeeze. Differences are minor and do not raise different issues of safety or effectiveness | | Blade material/ Patient contact & duration | Stainless Steel / Externally communicating, limited duration (< 24 hours) | Stainless Steel / Externally communicating, limited duration (< 24 hours) | Stainless Steel/ Externally communicating, limited duration (< 24 hours) | Subject device material, patient contact and duration is same as both predicates | | Vacuum and tissue collection | HERizon RD5™ Resecting Device is connected to an external suction source and tissue catch. | Benesta™ device is connected to an external suction source and tissue catch. | Resectr™ Device is connected to an external suction source and tissue catch. | Same | | Supplied accessories | None | None | None | Same | HERizon RD5™ Resecting Device Page 4 of 7 {8} K260984^{}[] Page 5 of 7 | Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Comparison | | --- | --- | --- | --- | --- | | Compatibility | Hysteroscopes with a working channel of 1.65 mm or larger | Hysteroscopes with a working channel of 4.0 mm (12F) | Hysteroscopes with a working channel of 1.65 mm or larger (5F) or 3.0 mm or larger (9F) | Subject device is same as one of two Resectr™ predicate device models. | | Bench testing | Range of mechanical, functional, and performance testing | Unknown | Range of mechanical, functional, and performance testing | Subject device was subjected to the same or similar bench testing as Resectr™ predicate device. Bench testing of primary predicate is unknown due to 510(k) statement | HERizon RD5™ Resecting Device Page 5 of 7 {9} K260984 Page 6 of 7 # NON-CLINICAL PERFORMANCE DATA # Biocompatibility Biocompatibility studies were performed in accordance with the 2023 FDA guidance document “Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process” and ISO 10993-1:2018 as follows for a device where the distal portion of the device has patient contact that is externally communicating with a limited duration of less than 24 hours: Cytotoxicity (ISO 10993-5:2009) Sensitization (ISO 10993-10:2021 Vaginal irritation (ISO 10993-23:2021) - Acute systemic toxicity (ISO 10993-11:2017) Material mediated pyrogenicity (ISO 10993-11:2017, USP<151>2017) # Sterilization The HERizon RD5™ Resecting Device is packaged for single use and terminally sterilized with Ethylene Oxide (EO). EO sterilization validation was performed per ISO 11135:2014/AMD 1:20218 ‘Sterilization of health care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices – Amendment 1: Revision of Annex E Single batch release.’ EO residuals were confirmed to be within ISO 10993-7:2008/AMD 1:2019 ‘Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.’. # Package Integrity Sterile barrier/packaging validation was performed following simulated shipping and handling per ASTM D4169 -23e1 ‘Standard Practice for Performance Testing of Shipping Containers and Systems’ and related standards as follows: - Visual seal inspection (ASTM F1886/F18886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection - ASTM F1929-23 Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - Pouch Seal Peel Strength Testing (ASTM F88/F88M-21 'Standard Test Method for Seal Strength of Flexible Barrier Materials') # Electrical Safety/EMC The battery powered HERizon RD5™ Resecting Device was tested and found to conform to the following electrical safety and EMC standards: Electrical safety (IEC 60601-1 Edition 3.2 2020-08 ‘Consolidated Version: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance’. HERizon RD5™ Resecting Device Page 6 of 7 {10} K260984 Page 7 of 7 IEC 60086-5 Primary Batteries – Part 5 with Aqueous Electrolytes EMC (IEC 60601-1-2:2014/AMD1:2020) # Mechanical/Functional Performance/Shelf-Life Testing Mechanical and functional performance testing was conducted on samples at baseline T = 0 and aged T = 1 year accelerated aging (per ASTM F1980). The performance tests completed to demonstrate that the HERizon RD5™ Resecting Device functions as intended include: - Cutting/Resection Performance - Device/Scope Compatibility - Dimensional Measurements - Durability - Functionality of Activation Button - Outer Tube (Cannula) Rotation - Vacuum Maintenance - Torque strength testing - Tensile testing All test results met the predefined acceptance criteria. # CLINICAL STUDIES No clinical studies were performed. # CONCLUSION The results of the above-described performance testing demonstrate that the HERizon RD5™ Resecting Device is as safe and effective as the predicate devices and supports a determination of substantial equivalence. HERizon RD5™ Resecting Device Page 7 of 7 --- **Source:** [https://fda-staging.innolitics.com/device/K260984](https://fda-staging.innolitics.com/device/K260984) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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