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Olympus Gf UC140P-AL5 Ultrasonic Endoscope with Aloka Ssd-5500 Ultrasound System

by Aloka Co., Ltd.

510(k) K011314

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK011314 Date15 May 2001ClearedStatusActive

Recalls

4 recalls · 2 ongoing · FDA

    • Ongoing Z-0333-2024 FDA Class II initiated 25 Sep 2023

    Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

    • Ongoing Z-1034-2022 FDA Class II initiated 18 Mar 2022

    GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients

  • 2 recalls, same reason

    • Terminated Z-0498-2021 FDA Class II initiated 16 Oct 2020
    • Terminated Z-0499-2021 FDA Class II initiated 16 Oct 2020

    A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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