K183004 is an FDA 510(k) clearance for the WEGO-PGA RAPID, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Foosin Medical Supplies Inc., Ltd. (Weihai, CN). The FDA issued a Cleared decision on January 28, 2019, 90 days after receiving the submission on October 30, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K183004 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2018 |
| Decision Date | January 28, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4493 |