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Fujifilm Ty-04D

by Fujifilm Corporation

Fujifilm Ty-04D is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K143556 on 20 Aug 2015 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04547410332094), 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) K143556

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 Number04547410332094 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143556 Date20 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143556 decided 20 Aug 2015 Active
  • FDA GUDID UDI-DI 04547410332094 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K143556
  2. Listed FDA GUDID 04547410332094

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  • Withdrawn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
TY-04D
Primary DI / UDI-DI
04547410332094
510(k) Number
FDA product code
FDF, FDA
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 (K143556)

and 1 more cleared under K143556

Similar devices

Other devices filed under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)