Foam Wound Dressing 66801692
by Smith & Nephew Medical, Ltd.
Foam Wound Dressing 66801692 is a Class II device made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K142979 on 29 Apr 2015 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00040565127132), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00040565127132 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142979 | Date29 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 00040565127132
- FDA 510(k) database K142979
Across registries
- FDA 510(k) K142979 decided 29 Apr 2015 Active
- FDA GUDID UDI-DI 00040565127132 listed 20 Sep 2016 Listed
Recalls
-
- Ongoing Z-2848-2016
Sterility seal integrity failures on the Renasys Sterile Transparent Film
Timeline
- Cleared FDA 510(k) K142979
- Recall initiated FDA recalls Z-2848-2016
- Listed FDA GUDID 00040565127132
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Foam Wound Dressing
- Generic name
- Wound dressing kit, medicated
- Model / Ref / Catalog
- 66801692
- Primary DI / UDI-DI
- 00040565127132
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Wound dressing kit, medicated
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
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