K222944 is an FDA 510(k) clearance for the SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture. This device is classified as a Suture, Nonabsorbable, Silk (Class II - Special Controls, product code GAP).
Submitted by Safepath Medical, Inc. (Amesbury, US). The FDA issued a Cleared decision on October 18, 2024, 753 days after receiving the submission on September 26, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5030.
| 510(k) Number | K222944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | October 18, 2024 |
| Days to Decision | 753 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAP - Suture, Nonabsorbable, Silk |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5030 |