K221767 is an FDA 510(k) clearance for the Surgical Sutures with or without Needle. This device is classified as a Suture, Nonabsorbable, Silk (Class II - Special Controls, product code GAP).
Submitted by Huaian Seamen Medical Technology Co., Ltd. (Huaian, CN). The FDA issued a Cleared decision on July 31, 2023, 409 days after receiving the submission on June 17, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5030.
| 510(k) Number | K221767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2022 |
| Decision Date | July 31, 2023 |
| Days to Decision | 409 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 |