Identifiers
- 510(k) Number
- K183001 FDA 510(k)
- FDA Product Code
- GAM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4493 FDA 510(k)
- Regulation Number
- 878.4493 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WEGO-PGLA RAPID is a traditional absorbable suturing device designed for general plastic surgery procedures, offering high-quality and secure suture placement. This device features a unique suture thread that prevents accidental tissue irritation, providing excellent hemostasis and minimizing post-operative bleeding.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183001 | Class II | Active |
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Manufacturer
- Manufacturer
- Foosin Medical Supplies Inc., Ltd.
Sources (1)
- FDA 510(k) K183001 24 fields · synced Oct 6, 2026