K982853 is an FDA 510(k) clearance for the SILK SUTURE. This device is classified as a Suture, Nonabsorbable, Silk (Class II - Special Controls, product code GAP).
Submitted by Davis & Geck, Inc. (Hazlewood, US). The FDA issued a Cleared decision on April 30, 1999, 260 days after receiving the submission on August 13, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5030.
| 510(k) Number | K982853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 13, 1998 |
| Decision Date | April 30, 1999 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAP — Suture, Nonabsorbable, Silk |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5030 |