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3NT Video Console CCU-0100

by 3nt Medical, Ltd.

3NT Video Console CCU-0100 is a Class II device made by 3nt Medical, Ltd., cleared under FDA 510(k) K192305 on 27 Feb 2020 and listed in FDA GUDID since 21 May 2020 (UDI-DI 07290016539097), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K192305

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 Number07290016539097 UDI-DI Date21 May 2020ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK192305 Date27 Feb 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192305 decided 27 Feb 2020 Active
  • FDA GUDID UDI-DI 07290016539097 listed 21 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192305
  2. Listed FDA GUDID 07290016539097

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
3NT Video Console
Generic name
Endoscopic video image processing unit
Model / Ref / Catalog
CCU-0100
Primary DI / UDI-DI
07290016539097
510(k) Number
FDA product code
EOB
GMDN term
Endoscopic video image processing unit
Device class
Class II
Regulation number
874.4760
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Endoscopic video image processing unit

Similar devices in this category

Other devices filed under Endoscopic video image processing unit.

Other devices from 3nt Medical, Ltd.

Properties

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