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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device anoscope and accessories
Regulation Description Endoscope and accessories.
Definition To examine and perform procedures within the anus and rectum.
Product CodeFER
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
THD SPA
  SUBSTANTIALLY EQUIVALENT 5
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 7
Material fragmentation 1
Gas leak 1
Output issue 1
Torn material 1
Break 1
Total Device Problems 12

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