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Fujifilm Aw-604g

by Fujifilm Corporation

Fujifilm Aw-604g is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K180711 on 25 May 2018 and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 04547410366037), 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) K180711

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 Number04547410366037 UDI-DI Date7 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK180711 Date25 May 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180711 decided 25 May 2018 Active
  • FDA GUDID UDI-DI 04547410366037 listed 7 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180711
  2. Listed FDA GUDID 04547410366037

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  • Withdrawn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
Endoscope air/water valve, reusable
Model / reference
AW-604G
Primary DI / UDI-DI
04547410366037
510(k) Number
FDA product code
FCX
GMDN term
Endoscope air/water valve, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope air/water valve, reusable

Cleared under the same submission (K180711)

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)