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McKesson 164

by Mckesson Medical-Surgical Inc.

McKesson 164 is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K073053 on 15 Nov 2007 and listed in FDA GUDID since 9 Dec 2016 (UDI-DI 40612479200003), 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) K073053

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 Number40612479200003 UDI-DI Date9 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK073053 Date15 Nov 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K073053 decided 15 Nov 2007 Active
  • FDA GUDID UDI-DI 40612479200003 listed 9 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K073053
  2. Listed FDA GUDID 40612479200003

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  • Withdrawn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
Colposcope
Model / reference
164
Primary DI / UDI-DI
40612479200003
510(k) Number
FDA product code
HEX
GMDN term
Colposcope
Device class
Class II
Regulation number
884.1630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Colposcope

Cleared under the same submission (K073053)

and 8 more cleared under K073053

Similar devices

Other devices filed under FDA product code HEX (Colposcope (And Colpomicroscope)).

Other devices from Mckesson Medical-Surgical Inc.

See all devices from Mckesson Medical-Surgical Inc. →

Properties

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