Urethral Balloon Dilation Catheter Set

• • Terminated Z-0970-2020 FDA Class II ·initiated 4 Jan 2019

  The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

510(k) Number

K892855 ↗

FDA Product Code

KOE

Device Class

Class II

Regulation

21 CFR Part 876.5520

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 3 Way Silicone Foley Balloon Catheter

  Class II

  FDA 510(k) K091767 Active Cleared 9 Oct 2009

• Aq Hydrophilic Dilators

  Class II

  FDA 510(k) K961904 Active Cleared 18 Oct 1996

• Bipolar Cutter

  Class II

  FDA 510(k) K955618 Active Cleared 22 Jan 1996

• Rutner Biopsy Device

  Class II

  FDA 510(k) K950810 Active Cleared 6 Mar 1995

• CO2 Pneumo-Dissector

  Class II

  FDA 510(k) K972647 Active Cleared 10 Apr 1998

• Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

  Class II

  FDA 510(k) K014160 Active Cleared 8 Feb 2002

See all devices from Cook Urological, Inc. →