K162396 is an FDA 510(k) clearance for the SILK Surgical Suture. This device is classified as a Suture, Nonabsorbable, Silk (Class II - Special Controls, product code GAP).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 23, 2016, 89 days after receiving the submission on August 26, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5030.
| 510(k) Number | K162396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2016 |
| Decision Date | November 23, 2016 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAP — Suture, Nonabsorbable, Silk |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5030 |