K964935 is an FDA 510(k) clearance for the SUTURE LOCK. This device is classified as a Retention Device, Suture (Class I — General Controls, product code KGS).
Submitted by Smith & Nephew Endoscopy, Inc. (Mansfield, US). The FDA issued a Cleared decision on February 25, 1997, 77 days after receiving the submission on December 10, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.
| 510(k) Number | K964935 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 1996 |
| Decision Date | February 25, 1997 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGS — Retention Device, Suture |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4930 |