Olympus Eu-C60 Eus Exera Compact Endoscopic Ultrasound Center

• 2 recalls, same reason

  • Terminated Z-0505-2021 FDA Class II ·initiated 16 Oct 2020
  • Terminated Z-0506-2021 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.

510(k) Number

K010591 ↗

FDA Product Code

ODG

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Olympus Optical Co., Ltd. →