M.blue Plus FX892T
by Aesculap AG
M.blue Plus FX892T is a Class II device made by Aesculap AG, cleared under FDA 510(k) K192266 on 21 Nov 2019 and listed in FDA GUDID since 4 Mar 2020 (UDI-DI 04041906504984), active as of 12 Nov 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 | Number04041906504984 | Date4 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192266 | Date21 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 04041906504984
- FDA 510(k) database K192266
Across registries
- FDA 510(k) K192266 decided 21 Nov 2019 Active
- FDA GUDID UDI-DI 04041906504984 listed 4 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K192266
- Listed FDA GUDID 04041906504984
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- M.blue Plus
- Generic name
- Cerebrospinal fluid shunt valve programmer
- Model / Ref / Catalog
- FX892T
- Primary DI / UDI-DI
- 04041906504984
- 510(k) Number
- FDA product code
- JXG
- GMDN term
- Cerebrospinal fluid shunt valve programmer
- Device class
- Class II
- Regulation number
- 882.5550
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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