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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, biopsy, electric
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeKGE
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
APOLLO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
FUJI
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 2
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Failure to deliver energy 36
Foreign material 36
Break 19
No Known Device Problem 19
Cautery 16
Tear, rip or hole in device packaging 14
Electrical issue 13
Bent 11
Loose or intermittent connection 8
Other (for use when an appropriate device code cannot be identified) 8
No code available 8
Device handling issue 6
Failure to align 6
Device operates differently than expected 6
Detachment of device component 5
Output energy incorrect 4
Unknown (for use when the device problem is not known) 3
Heat, failure to 3
Connection issue 3
Torn material 2
Wire(s), breakage of 2
Difficult to remove 2
Retraction problem 2
Peeled 2
Device, or device fragments remain in patient 1
Defective component 1
Solder joint failure 1
Crack 1
Burn of device or device component 1
Material fragmentation 1
Tears, rips, holes in device, device material 1
Foreign material present in device 1
Material deformation 1
Material Protrusion 1
Failure to advance 1
Split 1
Failure to separate 1
Arcing 1
Device or device fragments location unknown 1
Spark 1
Close, difficult to 1
No Information 1
Malfunction 1
Output issue 1
Total Device Problems 254

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