• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device probe, radiofrequency lesion
Regulation Description Radiofrequency lesion probe.
Product CodeGXI
Regulation Number 882.4725
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DIROS TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
EPIMED
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
LCCS PRODUCTS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RELIEVANT MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Break 84
Adverse Event Without Identified Device or Use Problem 66
Material Separation 60
Material Discolored 53
Insufficient Heating 30
Contamination / decontamination Problem 29
Temperature Problem 22
Defective Device 17
Material Erosion 15
Leak / Splash 13
No Apparent Adverse Event 8
Electrode 8
Fluid Leak 5
Insufficient Information 4
Device Displays Incorrect Message 4
Detachment of Device or device Component 3
Electrical /Electronic Property Problem 3
Overheating of Device 3
Fracture 3
Device Operates Differently Than Expected 3
Smoking 3
Crack 3
Peeled / Delaminated 3
Communication or Transmission Problem 3
Grounding Malfunction 2
Use of Device Problem 2
Melted 2
Delivered as Unsterile Product 2
Appropriate Term/Code Not Available 2
High impedance 2
Sparking 2
Material Fragmentation 2
Cannula 1
Generator 1
Corroded 1
Improper or Incorrect Procedure or Method 1
Device Contamination with Body Fluid 1
Device Inoperable 1
Residue After Decontamination 1
Material Protrusion / Extrusion 1
Device Disinfection Or Sterilization Issue 1
Device Contamination with Chemical or Other Material 1
Detachment Of Device Component 1
Device Issue 1
Loss of Power 1
Impedance Problem 1
Cannula, Inner 1
Total Device Problems 476

Recalls
Manufacturer Recall Class Date Posted
1 Cosman Medical, LLC II Feb-22-2018
2 Halyard Health, Inc II Aug-11-2016
3 Kimberly-Clark Corporation II Jan-28-2014
4 Neurotherm, Inc. II Mar-24-2016

-
-