Identifiers
- 510(k) Number
- K902885 FDA 510(k)
- FDA Product Code
- KKX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CustomED Basic Pack II is a widely used, FDA-approved antimicrobial drape designed for general plastic surgery procedures. Its unique antimicrobial properties make it an essential tool in maintaining patient safety and reducing the risk of infection.
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 | K902885 | Class II | Active |
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Manufacturer
- Manufacturer
- Customed, Inc.
Sources (1)
- FDA 510(k) K902885 24 fields · synced Jul 12, 2026