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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device probe, radiofrequency lesion
Regulation Description Radiofrequency lesion probe.
Product CodeGXI
Regulation Number 882.4725
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 7
EPIMED
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
TECHNOMED EUROPE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 5
Temperature issue 3
Device displays error message 3
Device operates differently than expected 3
Electrical issue 2
Overheating of device or device component 2
No Information 2
Detachment of device component 1
Loss of power 1
Material separation 1
Device inoperable 1
Impedance issue 1
Not Applicable 1
Total Device Problems 26

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 1 0 0 0 0 0 0 0 0 0
Class II 0 0 1 1 0 1 1 1 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baylis Medical Company Inc. II Feb-26-2013
2 Baylis Medical Corp * II Jun-03-2010
3 Halyard Health, Inc II Aug-11-2016
4 Kimberly-Clark Corporation II Jan-28-2014
5 Neurotherm, Inc. II Mar-24-2016
6 Neurotherm, Inc. II Jan-13-2009
7 Smith & Nephew, Inc. Endoscopy Division I Mar-29-2007
8 Stryker Instruments Div. of Stryker Corporation II Aug-02-2012

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