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Clear Guide CORE CGCORE13

by Clear Guide Medical

Clear Guide CORE CGCORE13 (CG-CORE-13) is a Class II device made by Clear Guide Medical, cleared under FDA 510(k) K201898 on 31 Jul 2020 and listed in FDA GUDID since 6 Oct 2022 (UDI-DI B201CGCORE130), 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) K201898

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 NumberB201CGCORE130 UDI-DI Date6 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201898 Date31 Jul 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201898 decided 31 Jul 2020 Active
  • FDA GUDID UDI-DI B201CGCORE130 listed 6 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201898
  2. Listed FDA GUDID B201CGCORE130

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  • Withdrawn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 CORE
Generic name
Ultrasound imaging system workstation
Model / Ref / Catalog
CGCORE13, CG-CORE-13
Primary DI / UDI-DI
B201CGCORE130
510(k) Number
FDA product code
JAK
GMDN term
Ultrasound imaging system workstation
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: LUMENA

Related devices

Category: Portable computerOptical surgical navigation device tracking system workstation, mobileUltrasound imaging system workstationStereotactic surgery system workstation

Cleared under the same submission (K201898)

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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)