K231183 is an FDA 510(k) clearance for the Non absorbable Surgical Polyester Suture. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Shandong Haidike Medical Products Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on August 25, 2023, 121 days after receiving the submission on April 26, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K231183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2023 |
| Decision Date | August 25, 2023 |
| Days to Decision | 121 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 |