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Aps™ 8253054

by Medtronic Xomed Inc

Aps™ 8253054 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 00643169344983), active as of 8 Nov 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K083124

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169344983 UDI-DI Date7 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083124 Date27 Feb 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083124 decided 27 Feb 2009 Active
  • FDA GUDID UDI-DI 00643169344983 listed 7 Apr 2016 Listed

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2343-2012 FDA Class II initiated 27 Sep 2010
    • Terminated Z-2342-2012 FDA Class II initiated 27 Sep 2010
    • Terminated Z-2344-2012 FDA Class II initiated 27 Sep 2010

    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

5 dated events

  1. Cleared FDA 510(k) K083124
  2. Recall initiated FDA recalls Z-2343-2012
  3. Recall initiated FDA recalls Z-2342-2012
  4. Recall initiated FDA recalls Z-2344-2012
  5. Listed FDA GUDID 00643169344983

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aps™
Generic name
Nerve-locating system
Model / reference
8253054
Primary DI / UDI-DI
00643169344983
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
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Nerve-locating system

Cleared under the same submission (K083124)

and 8 more cleared under K083124

Similar devices

Other devices filed under FDA product code ETN (STIMULATOR, NERVE).

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)