Bml Series

• 4 recalls, same reason

  • Terminated Z-0107-2008 FDA Unclassified (pre-2012) ·initiated 20 Sep 2007
  • Terminated Z-0108-2008 FDA Unclassified (pre-2012) ·initiated 20 Sep 2007
  • Terminated Z-0105-2008 FDA Unclassified (pre-2012) ·initiated 20 Sep 2007
  • Terminated Z-0106-2008 FDA Unclassified (pre-2012) ·initiated 20 Sep 2007

  Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath

510(k) Number

K903529 ↗

FDA Product Code

LQC

Device Class

Class II

Regulation

21 CFR Part 876.4500

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. →