K163639 is an FDA 510(k) clearance for the LS-5 ePTFE Suture. This device is classified as a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II - Special Controls, product code NBY).
Submitted by Lsi Solutions (Victor, US). The FDA issued a Cleared decision on June 2, 2017, 161 days after receiving the submission on December 23, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5035.
| 510(k) Number | K163639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2016 |
| Decision Date | June 02, 2017 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NBY - Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5035 |