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Nim-Eclipse® 945NCCPULO

by Medtronic Xomed Inc 2 variants

Nim-Eclipse® 945NCCPULO is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K050798 on 15 Aug 2005 and listed in FDA GUDID since 14 May 2016 (UDI-DI 00643169553071), active as of 8 Nov 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

510(k) K050798

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 Number00643169553071 UDI-DI Date14 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050798 Date15 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050798 decided 15 Aug 2005 Active
  • FDA GUDID UDI-DI 00643169553071 listed 14 May 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050798
  2. Listed FDA GUDID 00643169553071

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nim-Eclipse®
Generic name
Nerve-locating system
Model / reference
945NCCPULO
Primary DI / UDI-DI
00643169553071
510(k) Number
FDA product code
GWJ, GWF, GWQ, IYN, ITX, GWE
GMDN term
Nerve-locating system
Device class
Class II
Regulation number
882.1900, 882.1870, 882.1400, 892.1550, 892.1570, 882.1890
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GWJ (STIMULATOR, AUDITORY, EVOKED RESPONSE).

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)