K930992 is an FDA 510(k) clearance for the FLEXON AND STAINLESS STEEL SUTURES. This device is classified as a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II - Special Controls, product code GAQ).
Submitted by American Cyanamid Co. (Danbury, US). The FDA issued a Cleared decision on December 17, 1993, 295 days after receiving the submission on February 25, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4495.
| 510(k) Number | K930992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1993 |
| Decision Date | December 17, 1993 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4495 |