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945VG202

by Medtronic Sofamor Danek, Inc.

945VG202 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 14 Jan 2018 (UDI-DI 00643169071643), active as of 22 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 22 Oct 2026

Documents

510(k) K061113

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169071643 UDI-DI Date14 Jan 2018ListedStatusListed 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 00643169071643 listed 14 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061113
  2. Listed FDA GUDID 00643169071643

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Visual stimulator
Model / reference
945VG202
Primary DI / UDI-DI
00643169071643
510(k) Number
FDA product code
IKN, GWF
GMDN term
Visual stimulator
Device class
Class II
Regulation number
890.1375, 882.1870
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code IKN (Electromyograph, diagnostic).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Serial number
Other properties (11, all answered No)