MediChoice 58160

by Owens & Minor Distribution, Inc.

MediChoice 58160 is a Class II device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K233578 on 22 Mar 2024 (1 earlier submission) and listed in FDA GUDID since 12 Mar 2025 (UDI-DI 20885632436069), 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

+1 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number20885632436069 UDI-DI	Date12 Mar 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK233578	Date22 Mar 2024Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK131407	Date12 Aug 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 20885632436069
FDA 510(k) database 510(k) number K233578
FDA 510(k) database 510(k) number K131407

Across registries

2 registries list this device

FDA 510(k) K233578 decided 22 Mar 2024 Active· +1 more in the status table
FDA GUDID UDI-DI 20885632436069 listed 12 Mar 2025 Listed

Timeline

3 dated events

12 Aug 2014 Cleared FDA 510(k) K131407
22 Mar 2024 Cleared FDA 510(k) K233578
12 Mar 2025 Listed FDA GUDID 20885632436069

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: MediChoice
Generic name: Sterilization container filter, single-use
Model / reference: 58160

Primary DI / UDI-DI: 20885632436069
510(k) Number: K131407
K233578
FDA product code: KCT
GMDN term: Sterilization container filter, single-use

Device class: Class II
Regulation number: 880.6850
GUDID distribution status: In Commercial Distribution

Other devices from Owens & Minor Distribution, Inc.

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

Properties

Lot / batch number

Other properties (14, all answered No)