K173747 is an FDA 510(k) clearance for the REXLENE. This device is classified as a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II - Special Controls, product code GAW).
Submitted by Sm Eng Co., Ltd. (Sasang-Gu, KR). The FDA issued a Cleared decision on December 21, 2018, 378 days after receiving the submission on December 8, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K173747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2017 |
| Decision Date | December 21, 2018 |
| Days to Decision | 378 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAW - Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5010 |