Identifiers
- 510(k) Number
- K102592 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 SUTRAZORB device is a minimally invasive surgical system used in general plastic surgery procedures, providing enhanced tissue stability and faster recovery times for patients. It is designed with absorbable sutures made from polyglycolic acid, offering a safe and effective alternative to traditional suture materials.
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 | K102592 | Class II | Active |
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Manufacturer
- Manufacturer
- Visionary Medical Supplies, Inc.
Sources (1)
- FDA 510(k) K102592 24 fields · synced Jul 18, 2026