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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, electrosurgical, active, urological, reprocessed
Regulation Description Endoscopic electrosurgical unit and accessories.
Definition The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. This device is indicated for reuse/reprocessing.
Product CodeNLW
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
STERILMED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Arcing 1
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Sterilmed Inc II Jan-13-2009

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