K230036 is an FDA 510(k) clearance for the Pre-Sutured Tendon (4561SC / Single Strand). This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on June 23, 2023, 178 days after receiving the submission on December 27, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K230036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2022 |
| Decision Date | June 23, 2023 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT - Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |