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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrocautery, gynecologic (and accessories)
Regulation Description Gynecologic electrocautery and accessories.
Product CodeHGI
Regulation Number 884.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
APPLE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 3
CAMERON-MILLER, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
GYNEX CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K070877  ENDOCERVICAL ELECTRODE # 2
THOMAS MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 3
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Electrical wires, defective 1
Wire(s), breakage of 1
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 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Dec-02-2014
2 Gynex Corporation III Oct-03-2012

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