K202994 is an FDA 510(k) clearance for the InnoClip Disposable Clip Applier, InnoClip Clip Applier. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Taiwan Surgical Corporation (Zhubei City, TW). The FDA issued a Cleared decision on January 4, 2022, 460 days after receiving the submission on October 1, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K202994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2020 |
| Decision Date | January 04, 2022 |
| Days to Decision | 460 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP - Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |