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Fujifilm Ec-530DL

by Fujifilm Corporation

Fujifilm Ec-530DL is a flexible video colonoscope (FDA Class II; FDA product code FDF, Colonoscope and accessories, flexible/rigid) made by Fujifilm Corporation, cleared under FDA 510(k) K142629 on 14 May 2015 and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410333305), 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) K142629

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 Number04547410333305 UDI-DI Date14 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142629 Date14 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142629 decided 14 May 2015 Active
  • FDA GUDID UDI-DI 04547410333305 listed 14 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142629
  2. Listed FDA GUDID 04547410333305

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  • Withdrawn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 colonoscope, reusable
Model / reference
EC-530DL
Primary DI / UDI-DI
04547410333305
510(k) Number
FDA product code
FDF
GMDN term
Flexible video colonoscope, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video colonoscope, reusable

Cleared under the same submission (K142629)

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