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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device cannula, manipulator/injector, uterine
Product CodeLKF
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHETER RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 4
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
CONCEPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 5
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ENDOCONTROL
  SUBSTANTIALLY EQUIVALENT 1
FEMASYS INC.
  SUBSTANTIALLY EQUIVALENT 4
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
MARINA MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OBG PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
THOMAS MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
UNIMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 3
Inflation issue 3
Tear, rip or hole in device packaging 3
Material separation 3
Hole in material 2
Break 2
Burst 1
Misconnection 1
Replace 1
Component falling 1
Crack 1
Disassembly 1
Unraveled material 1
Unknown (for use when the device problem is not known) 1
Device, removal of (non-implant) 1
Detachment of device or device component 1
Device operates differently than expected 1
Maintenance does not comply to manufacturers recommendations 1
No code available 1
Total Device Problems 29

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

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II Sep-02-2008
2 ConMed Corporation III Mar-03-2011
3 Cooper Surgical, Inc. II Nov-26-2012
4 CooperSurgical, Inc. II Jun-08-2015
5 CooperSurgical, Inc. II Sep-05-2014
6 CooperSurgical, Inc. II Jun-11-2014

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