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McKesson 1156

by Mckesson Medical-Surgical Inc.

McKesson 1156 is a Class II device made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K024197 on 3 Jan 2003 and listed in FDA GUDID since 9 Dec 2016 (UDI-DI 40612479199697), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K024197

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 Number40612479199697 UDI-DI Date9 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024197 Date3 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024197 decided 3 Jan 2003 Active
  • FDA GUDID UDI-DI 40612479199697 listed 9 Dec 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1131-2018 FDA Class II initiated 6 Oct 2017

    The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

Timeline

3 dated events

  1. Cleared FDA 510(k) K024197
  2. Listed FDA GUDID 40612479199697
  3. Recall initiated FDA recalls Z-1131-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
McKesson
Generic name
Foetal Doppler system
Model / reference
1156
Primary DI / UDI-DI
40612479199697
510(k) Number
FDA product code
KNG
GMDN term
Foetal Doppler system
Device class
Class II
Regulation number
884.2660
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)