K212603 is an FDA 510(k) clearance for the Non Absorbable Surgical Nylon Suture, a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Shandong Haidike Medical Product Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on December 22, 2021, 127 days after receiving the submission on August 17, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K212603 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 2021 |
| Decision Date | December 22, 2021 |
| Days to Decision | 127 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 |