K052701 is an FDA 510(k) clearance for the COROLENE, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Peters Surgical (Bobigny, FR). The FDA issued a Cleared decision on December 13, 2005, 76 days after receiving the submission on September 28, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K052701 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 2005 |
| Decision Date | December 13, 2005 |
| Days to Decision | 76 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 |