K133356 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE NONABSORBABLE SUTURE. This device is classified as a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II - Special Controls, product code GAW).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 6, 2013, 36 days after receiving the submission on October 31, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K133356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2013 |
| Decision Date | December 06, 2013 |
| Days to Decision | 36 days |
| Submission Type | Special |
| 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 |