K132464 is an FDA 510(k) clearance for the PTFE SURGICAL SUTURE, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Omnia Spa (Imola (Bo), IT). The FDA issued a Cleared decision on February 12, 2014, 189 days after receiving the submission on August 7, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.
| 510(k) Number | K132464 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2013 |
| Decision Date | February 12, 2014 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5035 |