InnoClip Clip Applier

{0} FDA U.S. FOOD & DRUG ADMINISTRATION December 22, 2025 Taiwan Surgical Corporation Ken Chen Primary Correspondent 3f., # 12, Sec. 12, Sheng Yi Rd., Hsinchu County Zhubei City, TW 30261 Taiwan Re: K253781 Trade/Device Name: InnoClip Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP, GDO Dated: July 29, 2025 Received: November 26, 2025 Dear Ken Chen: 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} K253781 - Ken Chen 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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} K253781 - Ken Chen 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, TEK N. LAMICHHANE -S Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K253781 | | | Device Name InnoClip™ Clip Applier | | | Indications for Use (Describe) InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} Page 1 of 3 510(k) Summary (K253781) This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92 Submitter: | Submitter: | TAIWAN SURGICAL CORPORATION | | --- | --- | | Mailing Address: | 3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County 302, Taiwan | | Phone Number: | +886-3-6588129 ext. 100 | | Fax Number: | +886-3-6588355 | | Contact Person: | Ken Chen | | Email: | ernest.chen@twsc.com.tw | | Date Prepared: | November26, 2025 | Device | Trade Name: | InnoClip Clip Applier | | --- | --- | | Common Name: | Implantable clip | | Classification Name: | Clip, Implantable | | Classification Name: | 878.4300 | | Classification Product Code: | FZP, GDO | | Device Class: | II | Predicate Device K202994, InnoClip Disposable Clip Applier, InnoClip Clip Applier (Primary) K150259, CLIP PLUS Disposable Clip Applier {5} Page 2 of 3 Device Description The InnoClip™ Clip Applier is a disposable clip cartridge contains 10, 16 or 20 implantable titanium clips, and should be used with “Taiwan Surgical” Reusable Clip Applier Handle. The product line includes two shaft diameters, 10 mm and 5 mm. Titanium clip sizes are 5.5 × 9.0 mm and 5.5 × 11 mm for the 10 mm applier, and 4.6 × 9.1 mm for the 5 mm applier. The applier is designed to be introduced through applicable trocar sleeves, or larger sleeves with a fitted converter. Indications for Use InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking. Indication for Use Comparison The InnoClip™ Clip Applier and the predicate device (K202994 InnoClip™ Clip Applier) has the same intended use as both devices are intended for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking. Technological Comparison The InnoClip™ Clip Applier demonstrates substantial equivalence in terms of intended use, technological characteristics, and performance. The subject device shares identical classification, indications for use, target population, contraindications, mechanism of action, energy source, functional operation, operating environment, patient contact time, sterilization method, and overall design with the predicate device. Minor differences were identified, including the addition of new 10 mm models, slight variations in patient-contacting materials for the 10 mm models. Non-Clinical and/or Clinical Tests Summary & Conclusion Biocompatibility Testing: Biocompatibility testing was conducted in accordance with ISO 10993-1:2018, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process. The devices are classified as externally communicating medical devices with contact to tissue, bone, or dentin for limited exposure (defined as cumulative single, multiple, or repeated use/contact of less than 24 hours). {6} Sterilization Validation: The sterilization process was validated to achieve a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO11137-1:2015 and ISO11137-2:2015. Shelf-life The 3-year shelf-life was established and validated through accelerated aging study conducted in accordance with ASTM F1980 and ISO11607-1/-2. Bench Performance Testing: Bench performance testing included evaluation of product assembly, clipped pull out force, clipped slip force, air tight capability, clipped gap, and clip force. The test results showed that the subject device has the similar device performance compared to the predicate device. ## Conclusion All test results demonstrate that the InnoClip™ Clip Applier meet their predefined acceptance criteria and intended use requirements. Therefore, the subject device (K253781) is considered as safe and effective as the predicate devices. Page 3 of 3