Skip to content

McKesson 78668

by Mckesson Medical-Surgical Inc.

McKesson 78668 is a Class II device made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K132998 on 20 Dec 2013 and listed in FDA GUDID since 12 Dec 2019 (UDI-DI 10612479250496), 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) K132998

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 Number10612479250496 UDI-DI Date12 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK132998 Date20 Dec 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132998 decided 20 Dec 2013 Active
  • FDA GUDID UDI-DI 10612479250496 listed 12 Dec 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132998
  2. Listed FDA GUDID 10612479250496

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  • Withdrawn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
Analytical non-scalp cutaneous electrode
Model / reference
78668
Primary DI / UDI-DI
10612479250496
510(k) Number
FDA product code
GXY
GMDN term
Analytical non-scalp cutaneous electrode
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Analytical non-scalp cutaneous electrode.

Other devices from Mckesson Medical-Surgical Inc.

See all devices from Mckesson Medical-Surgical Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)