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Fujifilm En-580T

by Fujifilm Corporation

Fujifilm En-580T is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K223295 on 11 Jan 2023 (2 earlier submissions) and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410330243), 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 NumberK223295 Date11 Jan 2023DecidedStatusActive
United StatesGUDID listing Number04547410330243 UDI-DI Date14 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223295 decided 11 Jan 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04547410330243 listed 14 Dec 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K143556
  2. Listed FDA GUDID 04547410330243
  3. Cleared FDA 510(k) K183683
  4. Cleared FDA 510(k) K223295

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  • Withdrawn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
Flexible video enteroscope
Model / reference
EN-580T
Primary DI / UDI-DI
04547410330243
510(k) Number
FDA product code
FDF, FDA
GMDN term
Flexible video enteroscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video enteroscope

Cleared under the same submission (K143556)

and 1 more cleared under K143556

Cleared under the same submission (K223295)

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
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)