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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device insufflator, laparoscopic
Regulation Description Laparoscopic insufflator.
Product CodeHIF
Regulation Number 884.1730
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARAGON SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
ELMED
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GENICON
  SUBSTANTIALLY EQUIVALENT 1
HIPPOKRATEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 9
LEXION MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 10
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 16
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 7
SOPRO
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SURGIQUEST, INC.
  SUBSTANTIALLY EQUIVALENT 3
TAUT
  SUBSTANTIALLY EQUIVALENT 1
VERESURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. GMBH
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 17
Occlusion within device 5
Normal 4
Device Issue 4
Device operates differently than expected 4
Infusion or flow issue 4
No flow 4
Detachment of device component 4
Excess flow or overinfusion 4
Break 3
Increase in pressure 3
Device inoperable 2
Use of Device Issue 2
Inflation issue 2
Use of Incorrect Control Settings 2
Foreign material present in device 2
Pressure, insufficient 2
Failure to deliver 2
No Information 2
Detachment of device or device component 2
Noise, Audible 1
Overheating of device or device component 1
Decrease in pressure 1
Device displays error message 1
Dislodged or dislocated 1
Gas leak 1
Improper flow or infusion 1
Packaging issue 1
Power source issue 1
Pressure issue 1
Deflation, cause unknown 1
No display or display failure 1
Inaccurate flowrate 1
Gas delivery system failure 1
Connection error 1
Air leak 1
Device alarm system issue 1
Not audible alarm 1
Loose or intermittent connection 1
Unknown (for use when the device problem is not known) 1
Seal, defective 1
Total Device Problems 95

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

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 Stryker Endoscopy II Apr-25-2016
3 Stryker Endoscopy II Mar-23-2010

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