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MediChoice MCL250AC

by CooperSurgical, Inc.

MediChoice MCL250AC is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K093393 on 24 Dec 2009 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 60888937010260), 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) K093393

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 Number60888937010260 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK093393 Date24 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093393 decided 24 Dec 2009 Active
  • FDA GUDID UDI-DI 60888937010260 listed 14 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K093393
  2. Listed FDA GUDID 60888937010260

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  • Withdrawn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
Noninvasive vascular ultrasound system
Model / reference
MCL250AC
Primary DI / UDI-DI
60888937010260
510(k) Number
FDA product code
JAF
GMDN term
Noninvasive vascular ultrasound system
Device class
Class II
Regulation number
892.1540
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JAF (Monitor, Ultrasonic, Nonfetal).

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)