Identifiers
- 510(k) Number
- K183004 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-Pga Rapid is an absorbable, synthetic, polyglycolic acid suture. It is designed for use in general and plastic surgery procedures.
This device is supplied as a single-use product. It has received FDA 510(k) clearance.
Frequently asked questions
What is the Wego-Pga Rapid used for?
This device is a synthetic, absorbable suture intended for use in general and plastic surgery procedures.
Is the Wego-Pga Rapid intended for reuse?
No, the Wego-Pga Rapid is supplied as a single-use product and must not be reused to ensure patient safety and device integrity.
What is the regulatory status of this suture?
The Wego-Pga Rapid has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to other legally marketed devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183004 | Class II | Active |
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Manufacturer
- Manufacturer
- Foosin Medical Supplies Inc., Ltd.
Sources (1)
- FDA 510(k) K183004 24 fields · synced Oct 6, 2026