Olympus Evs-Endoscopic Video Image & Data Sys

• • Terminated Z-2270-2018 FDA Class II ·initiated 11 May 2018

  Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.

• • Terminated Z-2269-2018 FDA Class II ·initiated 11 May 2018

  Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.

510(k) Number

K853585 ↗

FDA Product Code

FET

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Olympus Direct Bilirubin Reagent

  Class II

  FDA 510(k) K924963 Active Cleared 30 Nov 1992

• Olympus Chloride Reagent, Modification

  Class II

  FDA 510(k) K934136 Active Cleared 5 Nov 1993

• Resectoscope Sheath

  Class II

  FDA 510(k) K931994 Active Cleared 17 Feb 1994

• Olympus Measuring Devices

  Class II

  FDA 510(k) K933717 Active Cleared 2 Nov 1993

• Sterile Disposable Cytology Brush

  Not classified

  FDA 510(k) K802187 Active Cleared 10 Sep 1980

• Olympus Infant Resectoscope and Accessories

  Class II

  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →