K141206 is an FDA 510(k) clearance for the EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM. This device is classified as a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II - Special Controls, product code GAW).
Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on January 16, 2015, 252 days after receiving the submission on May 9, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K141206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2014 |
| Decision Date | January 16, 2015 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAW — Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5010 |