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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device speculum, vaginal, nonmetal
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHIB
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
ADEPT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPALT INC.
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
PLAYTEX PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRISM
  SUBSTANTIALLY EQUIVALENT 1
UNIMAR, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 10
Shipping damage or problem 8
No Information 1
Material fragmentation 1
Total Device Problems 20

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 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Jun-22-2015
2 Welch Allyn Inc II Oct-30-2015

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