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Fujifilm Duodenoscope Model ED-530XT

by Fujifilm Medical Systems U.S.A, Inc.

510(k) K152257

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152257 Date21 Jul 2017ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-3225-2017 FDA Class II initiated 21 Jul 2017

    An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.

    • Terminated Z-3128-2017 FDA Class II initiated 9 Mar 2015

    Fujifilm is reporting a corrective action due to an FDA inspection.

    • Terminated Z-3129-2017 FDA Class II initiated 9 Mar 2015

    Fujifilm is conducting a corrective action due to an FDA inspection.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FDT
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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