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Fujifilm Ct-11g

by Fujifilm Corporation

Fujifilm Ct-11g is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K180711 on 25 May 2018 (1 earlier submission) and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04547410331608), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK180711 Date25 May 2018DecidedStatusActive
United StatesGUDID listing Number04547410331608 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180711 decided 25 May 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04547410331608 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133976
  2. Listed FDA GUDID 04547410331608
  3. Cleared FDA 510(k) K180711

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fujifilm
Generic name
Medical air low pressure hose
Model / reference
CT-11G
Primary DI / UDI-DI
04547410331608
510(k) Number
FDA product code
FCX
GMDN term
Medical air low pressure hose
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical air low pressure hose

Cleared under the same submission (K133976)

Cleared under the same submission (K180711)

Similar devices

Other devices filed under FDA product code FCX (INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE).

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)