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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device trocar
Regulation Description Trocar.
Product CodeDRC
Regulation Number 870.1390
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
HANSEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 74
Detachment of device component 19
Break 11
Leak 5
Physical resistance 3
Component(s), broken 3
Air leak 3
Device, or device fragments remain in patient 2
Foreign material present in device 2
Scratched material 1
Temperature issue 1
Difficult to remove 1
Tip breakage 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Device Issue 1
Malposition of device 1
Method, improper/incorrect 1
Bent 1
Crack 1
Difficult to insert 1
Kinked 1
Total Device Problems 135

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

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. D.B.A. Lone Star Medical Products II Oct-29-2014
2 Ethicon Endo-Surgery Inc II Jun-26-2015
3 Instrumed International, Inc. II Dec-16-2014
4 Medical Device Technologies, Inc. II Jul-13-2010
5 Merit Medical Systems, Inc. II Apr-12-2016

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