Clear Guide ONE CGONE

by Clear Guide Medical

Clear Guide ONE CGONE is a Class II device made by Clear Guide Medical, cleared under FDA 510(k) K141806 on 19 Sep 2014 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI B201CGONE0), 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

FDA submission, from GUDID

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	NumberB201CGONE0 UDI-DI	Date21 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK141806	Date19 Sep 2014Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K141806

Across registries

2 registries list this device

FDA 510(k) K141806 decided 19 Sep 2014 Active
FDA GUDID UDI-DI B201CGONE0 listed 21 Sep 2016 Listed

Timeline

2 dated events

19 Sep 2014 Cleared FDA 510(k) K141806
21 Sep 2016 Listed FDA GUDID B201CGONE0

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Clear Guide ONE
Generic name: Ultrasound imaging system application software
Model / reference: CGONE

Primary DI / UDI-DI: B201CGONE0
510(k) Number: K141806
FDA product code: IYO
GMDN term: Ultrasound imaging system application software

Device class: Class II
Regulation number: 892.1560
GUDID distribution status: In Commercial Distribution

From the manufacturer

Manufacturer's product page: LUMENA

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)