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Clear Guide Optical Head CGOH

by Clear Guide Medical

Clear Guide Optical Head CGOH (CG-OH) 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 B201CGOH0), 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) K141806

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 NumberB201CGOH0 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141806 Date19 Sep 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141806 decided 19 Sep 2014 Active
  • FDA GUDID UDI-DI B201CGOH0 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141806
  2. Listed FDA GUDID B201CGOH0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clear Guide Optical Head
Generic name
Radiological video camera patient positioning/tracking system camera
Model / Ref / Catalog
CGOH, CG-OH
Primary DI / UDI-DI
B201CGOH0
510(k) Number
FDA product code
IYO
GMDN term
Radiological video camera patient positioning/tracking system camera
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: LUMENA

Related devices

Category: Optical surgical navigation device tracking systemRadiological video camera patient positioning/tracking system camera

Cleared under the same submission (K141806)

Similar devices

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Other devices from Clear Guide Medical

See all devices from Clear Guide Medical →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)