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Nim 8220325

by Medtronic Xomed Inc

Ref 8220325

Nim 8220325 is a device classified as Class I in the EU and Class II in the US made by Medtronic Xomed Inc, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 0763000B000005577), cleared under FDA 510(k) K083124 on 27 Feb 2009 and listed in FDA GUDID since 3 Oct 2020 (UDI-DI 00763000293055), active as of 8 Nov 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083124

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000005577 Basic UDI-DI 00763000293055UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000293055 UDI-DI Date3 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083124 Date27 Feb 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000005577 registered 28 Sep 2026 Active
  • FDA 510(k) K083124 decided 27 Feb 2009 Active
  • FDA GUDID UDI-DI 00763000293055 listed 3 Oct 2020 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

6 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 00763000293055
  6. Registered EUDAMED 0763000B000005577

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Nim
Generic name
Nerve-locating system
Device name
Nim 3.0 Mute Detector
Model / reference
8220325
Primary DI / UDI-DI
00763000293055
Basic UDI-DI
0763000B000005577
510(k) Number
FDA product code
ETN, GWF
EMDN code
Z12101199 Peripheral or central neuro stimulation and assessment instruments - other
GMDN term
Nerve-locating system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.1820, 882.1870
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Nerve-locating system

Cleared under the same submission (K083124)

and 8 more cleared under K083124

Similar devices in this category

Other devices filed under PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - OTHER.

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)