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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sigmoidoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition to examine and perform procedures within the sigmoid (descending) colon
Product CodeFAM
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
PENTAX
  SUBSTANTIALLY EQUIVALENT 6
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 5
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Device Cleaning Issue 4
Device clogged 1
Device emits odor 1
Overheating of device or device component 1
Burn of device or device component 1
Total Device Problems 8

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