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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, circumcision
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHFX
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
BIONX
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENERIC MEDICAL DEVICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 12
Break 5
Device Issue 3
Defective item 3
No Information 2
Unknown (for use when the device problem is not known) 2
Detachment of device component 2
Loose 1
Misassembled 1
Slippage of device or device component 1
Use of Device Issue 1
Defective component 1
Malfunction 1
Failure to cut 1
Device, removal of (non-implant) 1
Device misassembled during manufacturing or shipping 1
No Known Device Problem 1
Not Applicable 1
Total Device Problems 40

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

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Mar-04-2014
2 Deroyal Industries, Inc. Lafollette II Sep-16-2011
3 Instrumed International, Inc. II Dec-16-2014
4 Surgical Design Inc II May-06-2011

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