K140415 is an FDA 510(k) clearance for the MONOTEX. This device is classified as a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II - Special Controls, product code NBY).
Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on March 26, 2014, 36 days after receiving the submission on February 18, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5035.
| 510(k) Number | K140415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2014 |
| Decision Date | March 26, 2014 |
| Days to Decision | 36 days |
| Submission Type | Abbreviated |
| 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 |