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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeKDC
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 2
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 10
Disconnection 9
Fluid leak 7
Device packaging compromised 7
No Known Device Problem 5
Foreign material present in device 3
Failure to deliver 3
Fracture 3
Material separation 3
Reflux within device 2
Insufficient flow or underinfusion 2
Inaccurate delivery 1
Detachment of device or device component 1
Packaging issue 1
Tears, rips, holes in device, device material 1
Air leak 1
Bleed back 1
Material fragmentation 1
Total Device Problems 61

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

Recalls
Manufacturer Recall Class Date Posted
1 Hospira Inc. II Apr-19-2011
2 J. Jamner Surgical Instruments, Inc. III Mar-08-2007
3 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
4 Scanlan International Inc II Apr-03-2007
5 Tri-State Hospital Supply Corporation III Feb-23-2008

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