Aps™ 8228052
Aps™ 8228052 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K083124 on 27 Feb 2009 and listed in FDA GUDID since 7 Apr 2016 (UDI-DI 00643169309326), active as of 8 Nov 2026. 3 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169309326 | Date7 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083124 | Date27 Feb 2009 | StatusActive |
Official records
- AccessGUDID record 00643169309326
- FDA 510(k) database K083124
Across registries
- FDA 510(k) K083124 decided 27 Feb 2009 Active
- FDA GUDID UDI-DI 00643169309326 listed 7 Apr 2016 Listed
Recalls
-
- Terminated Z-2343-2012
- Terminated Z-2342-2012
- Terminated Z-2344-2012
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Timeline
- Cleared FDA 510(k) K083124
- Recall initiated FDA recalls Z-2343-2012
- Recall initiated FDA recalls Z-2342-2012
- Recall initiated FDA recalls Z-2344-2012
- Listed FDA GUDID 00643169309326
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aps™
- Generic name
- Nerve-locating system
- Model / reference
- 8228052
- Primary DI / UDI-DI
- 00643169309326
- 510(k) Number
- FDA product code
- ETN, GWF
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 874.1820, 882.1870
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 2.0 Millimeter
Similar devices
Other devices filed under FDA product code ETN (STIMULATOR, NERVE).
- 534675 by inomed Medizintechnik GmbH
- NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR by The Magstim Company, Ltd.
- ISIS 504005 by inomed Medizintechnik GmbH
- Cadwell Guardian 190312-200 by Cadwell Industries, Inc.
- NUVASIVE NEUROVISION JJB SYSTEM by Nuvasive, Inc.
- MODEL 6110C OTOPHOR by Life-Tech Intl., Inc.
- Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large by Checkpoint Surgical, Inc.
- MODIFICATION TO CAVERMAP SURGICAL AID by Uromed Corp.
- AXOSTIM NERVE STIMULATOR, MODIFICATION by Singer Medical Products, Inc.
- NERVE INTEGRITY MONITOR-2 (NIM-2 XL) by Xomed-Treace, Inc.