Illuminated Ureteral Catheter

• • Terminated Z-1870-2017 FDA Class II ·initiated 7 Mar 2017

  Product may overheat, melt, and burn patient.

510(k) Number

K923436 ↗

FDA Product Code

FCS

Device Class

Class II

Regulation

21 CFR Part 876.4020

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 3 Way Silicone Foley Balloon Catheter

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• Aq Hydrophilic Dilators

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• Bipolar Cutter

  Class II

  FDA 510(k) K955618 Active Cleared 22 Jan 1996

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  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. →