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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hysteroscope (and accessories)
Regulation Description Hysteroscope and accessories.
Product CodeHIH
Regulation Number 884.1690
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONCEPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 6
FEMICARE-NIKOMED LTD
  SUBSTANTIALLY EQUIVALENT 1
FRIGITRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 2
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 3
HENKE SASS WOLF
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
INTERLACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 12
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
OPTIVIA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
OPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 6
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 195
No Known Device Problem 67
Device handling issue 43
Material separation 36
Detachment of device component 22
Material opacification 12
No code available 10
Mechanical jam 7
Mechanics altered 7
Overheating of device or device component 6
Other (for use when an appropriate device code cannot be identified) 5
Material perforation 5
Bent 5
Fire 4
Suction issue 4
Product quality issue 3
Difficult to insert 3
Leak 3
Burn of device or device component 3
Component falling 3
Detachment of device or device component 3
Device operates differently than expected 2
Device packaging compromised 2
Device, removal of (non-implant) 2
Malfunction 2
Component missing 2
Device Issue 2
Arcing 2
Failure to cut 2
Normal 2
Fluid leak 2
Metal shedding debris 2
Unknown (for use when the device problem is not known) 2
Electro-magnetic interference (EMI) 2
Device Difficult to Setup or Prepare 2
Particulates 1
Smoking 1
Tip breakage 1
Use of Device Issue 1
Device damaged prior to use 1
Fitting problem 1
Fracture 1
Material fragmentation 1
Device emits odor 1
Melted 1
Difficult to deploy 1
Incorrect display 1
Absorption 1
Defective item 1
Dull 1
Failure to align 1
Dent in material 1
Misfire 1
Communication or transmission issue 1
Connection issue 1
Electrical shorting 1
Flare or flash 1
Improper flow or infusion 1
Material deformation 1
Positioning Issue 1
Scratched material 1
Temperature issue 1
Total Device Problems 501

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0


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