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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGEN
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
J. JAMNER
  SUBSTANTIALLY EQUIVALENT 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCHOLTEN SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOLOS ENDOSCOPY, INC
  SUBSTANTIALLY EQUIVALENT 4
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 31
Tip breakage 7
Other (for use when an appropriate device code cannot be identified) 6
Device operates differently than expected 4
Difficult to remove 3
Detachment of device component 3
Fracture 2
Replace 2
Use of Device Issue 2
Difficult to open or close 2
Misassembled by Users 2
No Information 1
No code available 1
No Known Device Problem 1
Component missing 1
Sticking 1
Material fragmentation 1
Linear 1
User used incorrect product for intended use 1
Component falling 1
Failure to fold 1
Total Device Problems 74

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Sep-09-2010
2 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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