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McKesson 22-A901

by Mckesson Medical-Surgical Inc.

McKesson 22-A901 is a Class II device made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K000961 on 19 Apr 2000 and listed in FDA GUDID since 9 Dec 2016 (UDI-DI 10612479213064), 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) K000961

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 Number10612479213064 UDI-DI Date9 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK000961 Date19 Apr 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000961 decided 19 Apr 2000 Active
  • FDA GUDID UDI-DI 10612479213064 listed 9 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000961
  2. Listed FDA GUDID 10612479213064

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  • Withdrawn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
Electrosurgical handpiece, single-use
Model / reference
22-A901
Primary DI / UDI-DI
10612479213064
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical handpiece, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Electrosurgical handpiece, single-use

Cleared under the same submission (K000961)

and 2 more cleared under K000961

Similar devices in this category

Other devices filed under Electrosurgical handpiece, single-use.

Other devices from Mckesson Medical-Surgical Inc.

See all devices from Mckesson Medical-Surgical Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)