Penumbra System PAPS1
Penumbra System PAPS1 is a Class II device made by Penumbra, Inc., cleared under FDA 510(k) K122756 on 2 Oct 2012 and listed in FDA GUDID since 30 Jul 2016 (UDI-DI 00814548010038), 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 | Number00814548010038 | Date30 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122756 | Date2 Oct 2012 | StatusActive |
Official records
- AccessGUDID record 00814548010038
- FDA 510(k) database K122756
Across registries
- FDA 510(k) K122756 decided 2 Oct 2012 Active
- FDA GUDID UDI-DI 00814548010038 listed 30 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K122756
- Listed FDA GUDID 00814548010038
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- Withdrawn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
- PAPS1
- Primary DI / UDI-DI
- 00814548010038
- 510(k) Number
- FDA product code
- JCX
- GMDN term
- Surgical irrigation/aspiration system
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
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