K173922 is an FDA 510(k) clearance for the C-PTFETM Surgical Suture, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Cp Medical, Inc. (Norcross, US). The FDA issued a Cleared decision on March 26, 2018, 90 days after receiving the submission on December 26, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.
| 510(k) Number | K173922 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 26, 2017 |
| Decision Date | March 26, 2018 |
| Days to Decision | 90 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 |