Nucleus Z207527
by Cochlear
Nucleus Z207527 is a Class III device made by Cochlear, approved under FDA PMA P970051 on 25 Jun 1998 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 09321502017176), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09321502017176 | Date24 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP970051 | Date25 Jun 1998 | StatusActive |
Official records
- AccessGUDID record 09321502017176
- FDA PMA database P970051
Across registries
- FDA PMA P970051 decided 25 Jun 1998 Active
- FDA GUDID UDI-DI 09321502017176 listed 24 Sep 2014 Listed
Recalls
-
- Terminated Z-2155-2015
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
-
- Terminated Z-0003-2012
Cochlear implant may shut down and cease to function.
-
- Terminated Z-0119-2010
Cochlear implant device component was mis-labeled.
Timeline
- Approved FDA PMA P970051
- Recall initiated FDA recalls Z-0119-2010
- Recall initiated FDA recalls Z-0003-2012
- Listed FDA GUDID 09321502017176
- Recall initiated FDA recalls Z-2155-2015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Nucleus
- Generic name
- Cochlear implant/auditory brainstem implant external coil cable
- Model / Ref / Catalog
- Z207527
- Primary DI / UDI-DI
- 09321502017176
- PMA number
- FDA product code
- MCM
- GMDN term
- Cochlear implant/auditory brainstem implant external coil cable
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 28 Centimeter