MicroDoc NPWT System 8463550 5013
MicroDoc NPWT System 8463550 5013 is a Class II device made by Pensar Medical, LLC, cleared under FDA 510(k) K200223 on 23 Oct 2020 and listed in FDA GUDID since 19 Mar 2025 (UDI-DI 00851978007788), 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 | Number00851978007788 | Date19 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200223 | Date23 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 00851978007788
- FDA 510(k) database K200223
Across registries
- FDA 510(k) K200223 decided 23 Oct 2020 Active
- FDA GUDID UDI-DI 00851978007788 listed 19 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K200223
- Listed FDA GUDID 00851978007788
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MicroDoc NPWT System
- Generic name
- Negative-pressure wound therapy system, electric, single-use
- Model / reference
- 8463550 5013
- Primary DI / UDI-DI
- 00851978007788
- 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
- Sterilisation method
- Ethylene Oxide
Similar devices in this category
Other devices filed under Negative-pressure wound therapy system, electric, single-use.