K960653 is an FDA 510(k) clearance for the MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED). This device is classified as a Suture, Absorbable, Synthetic (Class II - Special Controls, product code GAN).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 28, 1996, 42 days after receiving the submission on February 15, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K960653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1996 |
| Decision Date | March 28, 1996 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAN — Suture, Absorbable, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |