WoundPro Outer Drape 8463540 0639
WoundPro Outer Drape 8463540 0639 is a negative-pressure wound therapy system drape (FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump) made by Pensar Medical, LLC, cleared under FDA 510(k) K150960 on 1 Dec 2016 and listed in FDA GUDID since 10 Oct 2022 (UDI-DI 10851978007372), active as of 23 Oct 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 | Number10851978007372 | Date10 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150960 | Date1 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 10851978007372
- FDA 510(k) database K150960
Across registries
- FDA 510(k) K150960 decided 1 Dec 2016 Active
- FDA GUDID UDI-DI 10851978007372 listed 10 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K150960
- Listed FDA GUDID 10851978007372
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- WoundPro Outer Drape
- Generic name
- Negative-pressure wound therapy system drape
- Model / reference
- 8463540 0639
- Primary DI / UDI-DI
- 10851978007372
- 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
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