MicroDoc NPWT Control Unit 8463550 1002
MicroDoc NPWT Control Unit 8463550 1002 is a negative-pressure wound therapy system (FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump) made by Pensar Medical, LLC, cleared under FDA 510(k) K200223 on 23 Oct 2020 and listed in FDA GUDID since 6 Oct 2022 (UDI-DI 00851978007467), active as of 22 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 | Number00851978007467 | Date6 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200223 | Date23 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 00851978007467
- FDA 510(k) database K200223
Across registries
- FDA 510(k) K200223 decided 23 Oct 2020 Active
- FDA GUDID UDI-DI 00851978007467 listed 6 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K200223
- Listed FDA GUDID 00851978007467
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MicroDoc NPWT Control Unit
- Generic name
- Negative-pressure wound therapy system, electric, single-use
- Model / reference
- 8463550 1002
- Primary DI / UDI-DI
- 00851978007467
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Negative-pressure wound therapy system, electric, single-use
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Negative-pressure wound therapy system, electric, single-use.