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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device choledochoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition to examine and perform procedures within the bile ducts.
Product CodeFBN
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
PENTAX
  SUBSTANTIALLY EQUIVALENT 3
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 5
Break 2
Material perforation 1
Torn material 1
No Information 1
Normal 1
Peeled 1
Material separation 1
Device packaging compromised 1
Locking mechanism failure 1
Total Device Problems 15

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