K931271 is an FDA 510(k) clearance for the ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE. This device is classified as a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II - Special Controls, product code GAQ).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 7, 1994, 305 days after receiving the submission on March 8, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4495.
| 510(k) Number | K931271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1993 |
| Decision Date | January 07, 1994 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4495 |