Skip to content

NIM-Eclipse 945NCCPUE4

by Medtronic Sofamor Danek, Inc. 2 variants

NIM-Eclipse 945NCCPUE4 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K061113 on 23 May 2006 and listed in FDA GUDID since 22 Oct 2020 (UDI-DI 00763000384180), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K061113

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000384180 UDI-DI Date22 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061113 Date23 May 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061113 decided 23 May 2006 Active
  • FDA GUDID UDI-DI 00763000384180 listed 22 Oct 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061113
  2. Listed FDA GUDID 00763000384180

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  • Withdrawn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
Portable computer
Model / reference
945NCCPUE4
Primary DI / UDI-DI
00763000384180
510(k) Number
FDA product code
GWF, IYN
GMDN term
Portable computer
Device class
Class II
Regulation number
882.1870, 892.1550
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Portable computer

Cleared under the same submission (K061113)

and 1 more cleared under K061113

Similar devices

Other devices filed under FDA product code GWF (STIMULATOR, ELECTRICAL, EVOKED RESPONSE).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

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