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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
Foreign material 36
Failure to deliver energy 33
Break 16
No Known Device Problem 16
Cautery 16
Electrical issue 13
Bent 11
No code available 8
Other (for use when an appropriate device code cannot be identified) 8
Loose or intermittent connection 8
Detachment of device component 5
Output energy incorrect 4
Unknown (for use when the device problem is not known) 3
Connection issue 3
Device handling issue 3
Failure to align 3
Heat, failure to 3
Torn material 2
Wire(s), breakage of 2
Peeled 2
Retraction problem 2
Device operates differently than expected 2
Difficult to remove 2
Tears, rips, holes in device, device material 1
Spark 1
Device, or device fragments remain in patient 1
Defective component 1
Failure to advance 1
Arcing 1
Material deformation 1
Failure to separate 1
Material Protrusion 1
Material fragmentation 1
No Information 1
Crack 1
Split 1
Device or device fragments location unknown 1
Output issue 1
Burn of device or device component 1
Malfunction 1
Close, difficult to 1
Total Device Problems 219

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