Taiwan Surgical Corporation · Class II · Cleared Dec 22, 2025
| K-number | K253903 |
| Device name | InnoClip Disposable 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 Disposable Clip Applier is a surgical instrument consisting of a handle and 10, 16, or 20 implantable titanium clips in two shaft diameters (10 mm and 5 mm). It is indicated for laparoscopic surgical procedures to occlude blood vessels, ducts, and other tubular structures, and for radiographic marking.
The 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 exist in component parts and materials within the applier.
ISO 10993-1:2018 (biocompatibility), ISO 11137-1:2015 and ISO 11137-2:2015 (sterilization validation), ASTM F1980 and ISO 11607-1/-2 (shelf-life accelerated aging study), and bench performance testing per device specifications.
The InnoClip Disposable Clip Applier demonstrates substantial equivalence to the predicate device (K202994) because both devices have identical intended use, design, mechanism of action, and sterilization methods. Bench performance testing showed similar performance characteristics, and all biocompatibility and sterilization validation tests met acceptance criteria, confirming the subject device is as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov