colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

{0}  September 14, 2026 Ovesco Endoscopy AG % Maria Kiel Project Manager Novineon CRO GmbH Friedrich-Miescher-Strasse 9 Tuebingen, 72076 Germany Re: K253481 Trade/Device Name: colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligation Regulatory Class: Class II Product Code: PKL, FDI, KNS, OCZ Dated: August 13, 2026 Received: August 13, 2026 Dear Maria Kiel: 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} K253481 - Maria Kiel 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 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- {2} K253481 - Maria Kiel Page 3 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, Ph.D. 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 {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. | K253481 | ? | | Please provide the device trade name(s). | | ? | | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | | | | Please provide your Indications for Use below. | | ? | | colonic FTRD Set and diagnostic FTRD Set: Instrument for flexible endoscopy, for full thickness resection and diagnostic tissue acquisition through the removal of suitable lesions in the colorectum. The colonic FTRD is indicated for the resection of lesions < 3 cm in the colon and rectum. Resection sizes may be less than 3 cm due to targeted tissue thickness and degree of fibrosis. The diagnostic FTRD is indicated for the resection of lesions < 2.5 cm in the colon and rectum. Resection sizes may be less than 2.5 cm due to targeted tissue thickness and degree of fibrosis. gastroduodenal FTRD Set: Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum. The gastroduodenal FTRD is indicated for the resection of lesions < 2.5 cm in the stomach and duodenum. Resection sizes may be less than 2.5 cm due to target tissue thickness and degree of fibrosis. For the resection of subepithelial tumors (SETs) the resection size is limited by the inner cap diameter. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) #: K253481 # 510(k) Summary K253481 Page 1 of 3 Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Ovesco Endoscopy AG | | --- | --- | | Applicant Address | Friedrich-Miescher-Strasse 9 Tuebingen 72076 Germany | | Applicant Contact Telephone | +49707196528154 | | Applicant Contact | Mr. Antonio Caputo | | Applicant Contact Email | antonio.caputo@ovesco.com | | Correspondent Name | novineon CRO GmbH | | Correspondent Address | Friedrich-Miescher-Strasse 9 Tuebingen 72076 Germany | | Correspondent Contact Telephone | +49707198979134 | | Correspondent Contact | Dr. Maria Kiel | | Correspondent Contact Email | maria.kiel@novineon.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | | --- | --- | | Common Name | Hemostatic Metal Clip For The Gi Tract | | Classification Name | Hemorrhoidal ligator | | Regulation Number | 876.4400 | | Product Code(s) | PKL, FDI, KNS, OCZ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | --- | --- | --- | | K170867 | FTRD System Set | PKL | | K200684 | gastroduodenal FTRD Set | PKL | Device Description Summary 21 CFR 807.92(a)(4) The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. FTRD devices constitute memory-shape alloy clip mounted on a transparent plastic cap intended for full-thickness resection of tissue in the gastrointestinal tract. The FTRD System combines resection and closure using clip technology in a single procedure. The procedure sets consist of the following components: {5} - endoscope cap with preloaded clip and thread - FTRD snare integrated into cap's distal end - FTRD hand wheel - thread retriever - endoscope sleeve with fixation tapes - FTRD Marking Probe - FTRD Grasper - insertion balloon (gastroduodenal FTRD Set only) - guide wire (gastroduodenal FTRD Set only) K253481 Page 2 of 3 The colonic and the diagnostic FTRD are used in the colon and rectum. The gastroduodenal FTRD Set is applied in the stomach and duodenum. All FTRD devices share the following functional principle: An application cap is mounted on the tip of the endoscope. The application cap is fitted with an FTRD clip and an HF snare. Before using the FTRD System, the target lesion is marked with the FTRD Marking Probe (HF coagulation probe). The endoscope with the assembled system is guided to the resection site. The lesion is grasped and mobilized with the FTRD Grasper. Once the lesion is completely in the cap the clip is applied. After clip application the tissue is resected with the HF snare. In suitable lesions this enables the removal of all wall layers including the serosa. Scientific Concepts forming the basis for the device: - Established memory-shape alloy clips used for over-the-scope clip application in flexible endoscopy in the gastrointestinal tract. Significant Physical and Performance Characteristics: - Device Design: Device design is guided by compatibility with flexible endoscopes and device influence on endoscopic functions, e.g., vision and maneuverability. - Material Used: Materials used need to be sufficiently biocompatible considering the duration and nature of contact to the human body. - Physical Properties: Dimensions need to allow insertion via flexible endoscope into the gastrointestinal tract. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) colonic FTRD Set and diagnostic FTRD Set: Instrument for flexible endoscopy, for full thickness resection and diagnostic tissue acquisition through the removal of suitable lesions in the colorectum. The colonic FTRD is indicated for the resection of lesions < 3 cm in the colon and rectum. Resection sizes may be less than 3 cm due to targeted tissue thickness and degree of fibrosis. The diagnostic FTRD is indicated for the resection of lesions < 2.5 cm in the colon and rectum. Resection sizes may be less than 2.5 cm due to targeted tissue thickness and degree of fibrosis. gastroduodenal FTRD Set: Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum. The gastroduodenal FTRD is indicated for the resection of lesions < 2.5 cm in the stomach and duodenum. Resection sizes may be less than 2.5 cm due to target tissue thickness and degree of fibrosis. For the resection of subepithelial tumors (SETs) the resection size is limited by the inner cap diameter. ## Indications for Use Comparison 21 CFR 807.92(a)(5) Predicate Devices: For the Subject Device gastroduodenal FTRD Set the Predicate device is: Predicate Device: gastroduodenal FTRD Set Submission Number: K200684 Regulation Number: 876.4400 Product Code: PKL (hemostatic metal clip for the gi tract) For the Subject Devices colonic FTRD Set and diagnostic FTRD Set the Predicate device is: Predicate Device: FTRD System Set {6} Submission Number: K170867 Regulation Number: 876.4400 Product Code: PKL (hemostatic metal clip for the gi tract) K253481 Page 3 of 3 The proposed Predicate Devices are an earlier generation of the Subject Devices. The proposed Predicate Devices and the Subject Devices have the same intended use. The differences in the indications reflect the clarification and further specification of the already established applications and do not represent a new intended use. Differences in technical characteristics are identified. Questions of safety and effectiveness associated with these differences are shown to equally apply to the Predicate Devices. The identified differences therefore do not raise different questions of safety and effectiveness. Methods for investigating the effects of the device differences on safety and effectiveness are applied. Data from these methods support substantial equivalence. ## Technological Comparison 21 CFR 807.92(a)(6) The Subject Devices are a further development of the Predicate Devices. They share common technological aspects. I.e., all FTRD devices constitute over-the-scope clips intended for full-thickness resection of tissue in the gastrointestinal tract. The Subject Devices include design changes such as a different thread positioning and used materials for the application ring. However, it was concluded that these technological differences do not raise different questions of safety and effectiveness. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The sponsor manufactures a number of devices similar to the subject devices, including the predicate devices. Performance bench testing settings investigated key aspects of device safety and effectiveness. The devices were tested for functional capability and robustness, endoscope compatibility, clip application force, application ring strength, usability, MRI suitability and electrical safety. The testing was conducted for the predicate devices and was repeated for the subject devices, in case of relevant device changes. Not applicable - no clinical testing submitted for demonstration of substantial equivalence. The subject device was subjected to performance bench testing previously applied to other devices that constitute a cap attached to an endoscope tip for gastrointestinal clip application. The established precedent from these devices was met as evidenced by application of acceptance criteria and / or comparison to their respective performance bench testing results, thus indicating substantial equivalence.