Penumbra System PMXENGN-A
Penumbra System PMXENGN-A is a Class II device made by Penumbra, Inc., cleared under FDA 510(k) K180008 on 20 Jun 2018 and listed in FDA GUDID since 15 Aug 2018 (UDI-DI 00815948020023), 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 | Number00815948020023 | Date15 Aug 2018 | StatusListed |
| United States | FDA 510(k) | NumberK180008 | Date20 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 00815948020023
- FDA 510(k) database K180008
Across registries
- FDA 510(k) K180008 decided 20 Jun 2018 Active
- FDA GUDID UDI-DI 00815948020023 listed 15 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K180008
- Listed FDA GUDID 00815948020023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Penumbra System
- Generic name
- Surgical irrigation/aspiration system
- Model / reference
- PMXENGN-A
- Primary DI / UDI-DI
- 00815948020023
- 510(k) Number
- FDA product code
- NRY
- GMDN term
- Surgical irrigation/aspiration system
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe