Insemi-Cath II

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K954398 ↗

FDA Product Code

MFD

Device Class

Class II

Regulation

21 CFR Part 884.5250

Advisory Committee

Obstetrics/Gynecology

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. →