• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device coagulator-cutter, endoscopic, unipolar (and accessories)
Regulation Description Unipolar endoscopic coagulator-cutter and accessories.
Product CodeKNF
Regulation Number 884.4160
Device Class 2


Premarket Reviews
ManufacturerDecision
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
J. JAMNER
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 2
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDSYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fire 4
Break 3
No Known Device Problem 2
Torn material 2
Electrical issue 2
Unintended movement 1
Device handling issue 1
Temperature issue 1
Burn of device or device component 1
Material disintegration 1
Material fragmentation 1
Misassembled 1
Therapy delivered to incorrect body area 1
Material separation 1
Metal shedding debris 1
Malfunction 1
Failure to cut 1
Device operates differently than expected 1
Total Device Problems 26

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

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Feb-26-2013
2 Integra Limited II Jul-18-2012
3 LINA Medical ApS II Jun-28-2011

-
-