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Fujinon/Fujifilm Ultrasonic Endoscope Eg-530UR2 and Eg-530UT2

by Fujinon, Inc.

510(k) K120446

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120446 Date13 Aug 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0112-2014 FDA Class II initiated 31 Jul 2013

    A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.

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  • Withdrawn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
FDS
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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