K201139 is an FDA 510(k) clearance for the WEGO-PDO Barbed Suture. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by Foosin Medical Supplies Inc., Ltd. (Weihai, CN). The FDA issued a Cleared decision on October 20, 2020, 175 days after receiving the submission on April 28, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K201139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2020 |
| Decision Date | October 20, 2020 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW - Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4840 |