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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 1
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 8
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 9
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 54
Break 49
Device handling issue 43
Material separation 10
Other (for use when an appropriate device code cannot be identified) 5
Detachment of device component 4
No code available 4
Burn of device or device component 3
Fire 3
Fluid leak 2
Normal 2
Bent 2
Component falling 2
Electro-magnetic interference (EMI) 2
Unknown (for use when the device problem is not known) 2
Material perforation 2
Device Issue 2
Metal shedding debris 2
Mechanics altered 2
Malfunction 2
Arcing 2
Device, removal of (non-implant) 2
Device operates differently than expected 2
Electrical shorting 1
Improper flow or infusion 1
Defective item 1
Dent in material 1
Positioning Issue 1
Scratched material 1
Dull 1
Tip breakage 1
Use of Device Issue 1
Absorption 1
Particulates 1
Total Device Problems 214

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 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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