K920437 is an FDA 510(k) clearance for the SYNTHETIC ABSORBABLE SUTURE, UNDYED. 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 July 30, 1992, 178 days after receiving the submission on February 3, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K920437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1992 |
| Decision Date | July 30, 1992 |
| Days to Decision | 178 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 |