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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mini endoscope, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To examine and perform procedures in body cavities of the GI and GU tract.
Product CodeODF
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 3
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 5
Detachment of device component 3
Normal 3
Other (for use when an appropriate device code cannot be identified) 2
Unknown (for use when the device problem is not known) 1
Failure to advance 1
Split 1
No device output 1
Fitting problem 1
Crack 1
Torn material 1
Total Device Problems 20

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