K220091 is an FDA 510(k) clearance for the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on August 26, 2022, 226 days after receiving the submission on January 12, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K220091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2022 |
| Decision Date | August 26, 2022 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |