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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biopsy needle kit
Regulation Description Gastroenterology-urology biopsy instrument.
Product CodeFCG
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUSON
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
H.S. HOSPITAL SERVICES S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
HAAKO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 5
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Misfire 161
Break 103
Retraction problem 93
Loose 89
Bent 50
Unknown (for use when the device problem is not known) 35
No Known Device Problem 33
Occlusion within device 23
Other (for use when an appropriate device code cannot be identified) 22
Unstable 19
Difficult to advance 18
Difficult to remove 16
Material puncture 14
Detachment of device component 14
Kinked 11
Tip breakage 10
Material separation 10
Needle, separation 7
Detachment of device or device component 7
No code available 6
Failure to advance 6
Locking mechanism failure 4
Failure to obtain samples 4
Device Issue 4
Failure to deploy 4
Blockage within device or device component 3
Component(s), broken 3
Fracture 3
Needle, unsheathed 3
Sticking 3
Failure to fire 3
Device markings issue 2
Device-device incompatibility 2
Physical resistance 2
Fitting problem 2
Device handling issue 2
No Information 2
Foreign material present in device 2
Use of Device Issue 2
Material fragmentation 2
Difficult to deploy 2
Dislodged 1
Fluid leak 1
Handpiece break 1
Insulation, detached 1
Leak 1
Mechanical issue 1
Improper or incorrect procedure or method 1
Device inoperable 1
Unraveled material 1
Product quality issue 1
Device, or device fragments remain in patient 1
Normal 1
Unsealed device packaging 1
Device Difficult to Setup or Prepare 1
Slippage of device or device component 1
Sterility 1
Material integrity issue 1
Mechanical jam 1
Malfunction 1
Obstruction within device 1
Material perforation 1
Device damaged prior to use 1
Seal, defective 1
Device or device fragments location unknown 1
Catheter withdrawal interference 1
Total Device Problems 826

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 2 1 1 0 0 0 0 0
Class III 0 1 1 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Nov-17-2009
2 Boston Scientific Corp III Jan-12-2009
3 Boston Scientific Corporation III Sep-16-2011
4 Boston Scientific Corporation II Dec-27-2010
5 Boston Scientific Corporation III Nov-28-2008
6 Cardinal Health II Nov-09-2009
7 Olympus America Inc. II Oct-07-2011

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