Taiwan Surgical Corporation · Class II · Cleared Dec 22, 2025
| K-number | K253781 |
| Device name | InnoClip Clip Applier |
| Applicant | Taiwan Surgical Corporation |
| Product code | FZP |
| Device class | Class II |
| Decision date | Dec 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4300 |
The InnoClip Clip Applier is a disposable clip cartridge containing 10, 16, or 20 implantable titanium clips designed for use with a reusable handle. It is indicated for laparoscopic surgical procedures to occlude blood vessels, ducts, and other tubular structures, and for radiographic marking. The device comes in two shaft diameters (10 mm and 5 mm) with varying clip sizes.
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 include the addition of new 10 mm models and slight variations in patient-contacting materials for the 10 mm models.
ISO 10993-1:2018 (biocompatibility), ISO 11137-1:2015 and ISO 11137-2:2015 (sterilization validation), ASTM F1980 (shelf-life accelerated aging), and ISO 11607-1/-2 (shelf-life validation).
The InnoClip Clip Applier demonstrates substantial equivalence to predicate devices K202994 and K150259 because it has identical intended use, technological characteristics, and performance. Bench testing showed similar device performance compared to the predicate device, and all test results met predefined acceptance criteria, supporting the conclusion that the subject device is as safe and effective as the predicate devices.
View the full FDA submission: accessdata.fda.gov