K220980 is an FDA 510(k) clearance for the Tissue Approximation System (TAS). This device is classified as a Suture, Nonabsorbable, Synthetic, Polyamide (Class II - Special Controls, product code GAR).
Submitted by Tas Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on July 5, 2023, 457 days after receiving the submission on April 4, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K220980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | July 05, 2023 |
| Days to Decision | 457 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAR - Suture, Nonabsorbable, Synthetic, Polyamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5020 |