Cook Pediatric Flexor Ureteral Access Shealth

• • Terminated Z-0377-2007 FDA Unclassified (pre-2012) ·initiated 5 Jan 2007

  Lack of assurance of sterility, as the packages may not have been sealed.

510(k) Number

K043418 ↗

FDA Product Code

FED

Device Class

Class II

Regulation

21 CFR Part 876.1500

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. →