ExtriCARE ST403-0001
ExtriCARE ST403-0001 (EC-DRAPE) is a negative-pressure wound therapy system drape (FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump) made by Alleva Medical Limited, cleared under FDA 510(k) K140634 on 19 Sep 2014 and listed in FDA GUDID since 28 Dec 2023 (UDI-DI 04897089070217), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04897089070217 | Date28 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140634 | Date19 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 04897089070217
- FDA 510(k) database K140634
Across registries
- FDA 510(k) K140634 decided 19 Sep 2014 Active
- FDA GUDID UDI-DI 04897089070217 listed 28 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K140634
- Listed FDA GUDID 04897089070217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ExtriCARE
- Generic name
- Negative-pressure wound therapy system drape
- Model / Ref / Catalog
- ST403-0001, EC-DRAPE
- Primary DI / UDI-DI
- 04897089070217
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Negative-pressure wound therapy system drape
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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