Cochlear P1170466
by Cochlear
Cochlear P1170466 is a Class II device made by Cochlear, cleared under FDA 510(k) K191921 on 15 Nov 2019 and listed in FDA GUDID since 23 Nov 2019 (UDI-DI 09321502046152), 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 | Number09321502046152 | Date23 Nov 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191921 | Date15 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 09321502046152
- FDA 510(k) database K191921
Across registries
- FDA 510(k) K191921 decided 15 Nov 2019 Active
- FDA GUDID UDI-DI 09321502046152 listed 23 Nov 2019 Listed
Timeline
- Cleared FDA 510(k) K191921
- Listed FDA GUDID 09321502046152
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cochlear
- Generic name
- Bone-conduction hearing implant system vibrator assembly
- Model / Ref / Catalog
- P1170466
- Primary DI / UDI-DI
- 09321502046152
- 510(k) Number
- FDA product code
- PFO
- GMDN term
- Bone-conduction hearing implant system vibrator assembly
- Device class
- Class II
- Regulation number
- 874.3340
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code PFO (Active implantable bone conduction hearing system).
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- Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS by Oticon Medical AB
- Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments by Cochlear Americas
- Cochlear Osia System by Cochlear Americas