K151165 is an FDA 510(k) clearance for the Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyamide (Class II - Special Controls, product code GAR).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on February 17, 2016, 292 days after receiving the submission on May 1, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5020.
| 510(k) Number | K151165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2015 |
| Decision Date | February 17, 2016 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAR — Suture, Nonabsorbable, Synthetic, Polyamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5020 |