Pps Pi U201908
Pps Pi U201908 is a Class II device made by Perouse Medical, cleared under FDA 510(k) K120261 on 2 May 2012 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 03661234011186), 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 | Number03661234011186 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120261 | Date2 May 2012 | StatusActive |
Official records
- AccessGUDID record 03661234011186
- FDA 510(k) database K120261
Across registries
- FDA 510(k) K120261 decided 2 May 2012 Active
- FDA GUDID UDI-DI 03661234011186 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120261
- Listed FDA GUDID 03661234011186
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pps Pi
- Generic name
- Subcutaneous infusion/injection port needle
- Model / reference
- U201908
- Primary DI / UDI-DI
- 03661234011186
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Subcutaneous infusion/injection port needle
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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