• 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, bipolar (and accessories)
Regulation Description Bipolar endoscopic coagulator-cutter and accessories.
Product CodeHIN
Regulation Number 884.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ELMED
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 7
Material separation 4
Torn material 3
Difficult to remove 3
Normal 2
Bent 1
Not Applicable 1
Device handling issue 1
Arcing at electrodes 1
Failure to separate 1
Arcing 1
Device operates differently than expected 1
Component(s), overheating of 1
Entrapment of device or device component 1
Material fragmentation 1
Insulation, hole(s) in 1
Total Device Problems 30

-
-