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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, surgical, cryogenic
Regulation Description Cryogenic surgical device.
Product CodeGXH
Regulation Number 882.4250
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYOSCIENCE INC
  SUBSTANTIALLY EQUIVALENT 5
SPEMBLY CRYOSURGERY
  SUBSTANTIALLY EQUIVALENT 2
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device handling issue 1
Human-Device Interface Issue 1
No Known Device Problem 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 1 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Myoscience Inc II Jul-22-2015
2 Myoscience Inc II Jul-20-2013

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