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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device insufflator, hysteroscopic
Regulation Description Hysteroscopic insufflator.
Product CodeHIG
Regulation Number 884.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
BEI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 7
FRIGITRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
UNIMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. GMBH
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Pressure issue 2
Device Issue 1
Volume accuracy issue 1
Other (for use when an appropriate device code cannot be identified) 1
High Readings 1
No Known Device Problem 1
Output below specifications 1
Total Device Problems 8

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

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy America Inc II Nov-07-2007
2 Thermedx LLC II Apr-20-2015

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