K212888 is an FDA 510(k) clearance for the Golnit Nylon Monofilament Suture, a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Antarma, LLC Dba Golnit Sutures (New York, US). The FDA issued a Cleared decision on March 31, 2022, 202 days after receiving the submission on September 10, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K212888 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2021 |
| Decision Date | March 31, 2022 |
| Days to Decision | 202 days |
| Submission Type | Abbreviated |
| 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 |