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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, biopsy, non-electric, reprocessed
Regulation Description Gastroenterology-urology biopsy instrument.
Definition same as procode FCL except this product is for the reprocessed device.
Product CodeNON
Regulation Number 876.1075
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDISISS
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Retraction problem 5
Device operates differently than expected 1
Total Device Problems 6

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

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

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