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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, suction, lipoplasty
Regulation Description Suction lipoplasty system.
Product CodeMUU
Regulation Number 878.5040
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BLACK & BLACK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CYTORI THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
HARVEST
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
MEDELA
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE RESOURCE CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 2
MICROAIRE
  SUBSTANTIALLY EQUIVALENT 3
MILLENNIUM
  SUBSTANTIALLY EQUIVALENT 1
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOELLER
  SUBSTANTIALLY EQUIVALENT 2
RANFAC, CORP
  SUBSTANTIALLY EQUIVALENT 1
SHIPPERT MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 2
SOUND SURGICAL TECHNOLOGIES LLC.
  SUBSTANTIALLY EQUIVALENT 4
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 4
No Information 1
Failure to power-up 1
Material puncture 1
Suction issue 1
Device operates differently than expected 1
Total Device Problems 9

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 1 3
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Globalmed Logistix II Jan-25-2016
2 Mentor Texas, Inc III Sep-20-2007
3 Miami Fat Supply, Inc II Jun-14-2016
4 MicroAire Surgical Instruments, LLC II Sep-30-2015
5 Terumo BCT, Inc. II Nov-30-2016

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