Reprocessed Trocars, Model B5LT and CB5LT

• • Terminated Z-2468-2015 FDA Class II ·initiated 10 Jul 2015

  Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).

510(k) Number

K100080 ↗

FDA Product Code

NLM

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Reprocessed Cs Bi-Diectional Diagnostic Electrophysiology Catheter Open recall

  Class II

  FDA 510(k) K100254 Active Cleared 28 May 2010

• Reprocessed External Fixation Device

  Class II

  FDA 510(k) K061759 Active Cleared 5 Sep 2006

• Reprocessed Diagnostic Ultrasound Catheter

  Class II

  FDA 510(k) K063076 Active Cleared 29 Mar 2007

• Reprocessed Electrosurgical Instrument

  Class II

  FDA 510(k) K110189 Active Cleared 18 Jul 2011

• Reprocessed Trocars

  Class II

  FDA 510(k) K070059 Active Cleared 2 Oct 2007

• Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue

  Unclassified

  FDA 510(k) K100537 Active Cleared 12 May 2010

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