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Medichoice LHC1001

by Owens & Minor Distribution, Inc.

Medichoice LHC1001 is a Class II device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K053321 on 19 Jan 2006 and listed in FDA GUDID since 20 Aug 2016 (UDI-DI 10885632114632), 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) K053321

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 Number10885632114632 UDI-DI Date20 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK053321 Date19 Jan 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053321 decided 19 Jan 2006 Active
  • FDA GUDID UDI-DI 10885632114632 listed 20 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K053321
  2. Listed FDA GUDID 10885632114632

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medichoice
Generic name
Medical equipment handle cover, single-use
Model / reference
LHC1001
Primary DI / UDI-DI
10885632114632
510(k) Number
FDA product code
FTA
GMDN term
Medical equipment handle cover, single-use
Device class
Class II
Regulation number
878.4580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical equipment handle cover, single-use

Cleared under the same submission (K053321)

Similar devices in this category

Other devices filed under Medical equipment handle cover, single-use.

Other devices from Owens & Minor Distribution, Inc.

See all devices from Owens & Minor Distribution, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)