• 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 Back To Search Results
Device dislodger, stone, flexible
Regulation Description Ureteral stone dislodger.
Product CodeFGO
Regulation Number 876.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
SURGITEK
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 18
Peeled 13
Break 10
Close, difficult to 9
Difficult to open or close 7
Retraction problem 7
Material frayed 6
Device inoperable 5
Difficult to remove 5
Kinked 4
Failure to deploy 4
Detachment of device or device component 4
Malfunction 4
Mislabeled 3
Tip breakage 3
Mechanical issue 2
Difficult to insert 2
Device damaged prior to use 2
Defective item 2
Torn material 2
No code available 2
Device, removal of (non-implant) 1
Wire(s), breakage of 1
Device Issue 1
Physical resistance 1
Fracture 1
Bent 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Device, or device fragments remain in patient 1
Total Device Problems 123

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 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 US Endoscopy Group Inc II Oct-03-2012

-
-