Integrated Power Console 1898001LO
Integrated Power Console 1898001LO is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K081277 on 5 Sep 2008 and listed in FDA GUDID since 16 Oct 2017 (UDI-DI 00643169931404), active as of 8 Nov 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169931404 | Date16 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081277 | Date5 Sep 2008 | StatusActive |
Official records
- AccessGUDID record 00643169931404
- FDA 510(k) database K081277
Across registries
- FDA 510(k) K081277 decided 5 Sep 2008 Active
- FDA GUDID UDI-DI 00643169931404 listed 16 Oct 2017 Listed
Recalls
-
- Terminated Z-0961-2022
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
Timeline
- Cleared FDA 510(k) K081277
- Listed FDA GUDID 00643169931404
- Recall initiated FDA recalls Z-0961-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integrated Power Console
- Generic name
- Surgical power tool system control unit, pneumatic
- Model / reference
- 1898001LO
- Primary DI / UDI-DI
- 00643169931404
- 510(k) Number
- FDA product code
- ERL
- GMDN term
- Surgical power tool system control unit, pneumatic
- Device class
- Class II
- Regulation number
- 874.4250
- GUDID distribution status
- In Commercial Distribution
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