Phoenix Neuro P04
by Sophysa SA
Phoenix Neuro P04 is a Class II device made by Sophysa SA, cleared under FDA 510(k) K853371 on 18 Sep 1985 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03760124136678), active as of 23 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 | Number03760124136678 | Date16 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK853371 | Date18 Sep 1985 | StatusActive |
Official records
- AccessGUDID record 03760124136678
- FDA 510(k) database K853371
Across registries
- FDA 510(k) K853371 decided 18 Sep 1985 Active
- FDA GUDID UDI-DI 03760124136678 listed 16 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K853371
- Listed FDA GUDID 03760124136678
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Phoenix Neuro
- Generic name
- Peritoneal/atrial cerebrospinal fluid catheter
- Model / reference
- P04
- Primary DI / UDI-DI
- 03760124136678
- 510(k) Number
- FDA product code
- JXG
- GMDN term
- Peritoneal/atrial cerebrospinal fluid catheter
- Device class
- Class II
- Regulation number
- 882.5550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Peritoneal/atrial cerebrospinal fluid catheter.