K180992 is an FDA 510(k) clearance for the Biotex. This device is classified as a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II - Special Controls, product code NBY).
Submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 16, 2019, 456 days after receiving the submission on April 16, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5035.
| 510(k) Number | K180992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2018 |
| Decision Date | July 16, 2019 |
| Days to Decision | 456 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 |