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McKesson 16-585E-GR

by Mckesson Medical-Surgical Inc.

McKesson 16-585E-GR is a Class I device made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K953107 on 15 Aug 1995 and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 10612479274294), 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) K953107

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 Number10612479274294 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK953107 Date15 Aug 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K953107 decided 15 Aug 1995 Active
  • FDA GUDID UDI-DI 10612479274294 listed 31 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K953107
  2. Listed FDA GUDID 10612479274294

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  • Withdrawn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
Anaesthesia face mask, single-use
Model / reference
16-585E-GR
Primary DI / UDI-DI
10612479274294
FDA product code
BSJ
GMDN term
Anaesthesia face mask, single-use
Device class
Class I
Regulation number
868.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Anaesthesia face mask, single-use

Cleared under the same submission (K953107)

and 8 more cleared under K953107

Similar devices in this category

Other devices filed under Anaesthesia face mask, single-use.

Other devices from Mckesson Medical-Surgical Inc.

See all devices from Mckesson Medical-Surgical Inc. →

Properties

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