Cabot Medical Bipolar Cutting Forceps

• 3 recalls, same reason

  • Terminated Z-0613-2007 FDA Unclassified (pre-2012) ·initiated 19 Feb 2007
  • Terminated Z-0614-2007 FDA Unclassified (pre-2012) ·initiated 19 Feb 2007
  • Terminated Z-0615-2007 FDA Unclassified (pre-2012) ·initiated 19 Feb 2007

  Product sterility may be compromised due to failure of the tray seal packaging

510(k) Number

K932293 ↗

FDA Product Code

KNS

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K932977 Active Cleared 7 Sep 1993

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  FDA 510(k) K932626 Active Cleared 8 Jun 1994

• Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths

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  FDA 510(k) K951972 Active Cleared 21 Jul 1995

• Cabot Disposable 10mm Suction Device

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  FDA 510(k) K924048 Active Cleared 22 Jan 1993

• Pleatman Sac Specimen Container

  Class II

  FDA 510(k) K923945 Active Cleared 5 Feb 1993

• Corson and Nezhat Suction/Irrigation Probes

  Class II

  FDA 510(k) K935786 Active Cleared 19 May 1994

See all devices from Cabot Medical Corp. →