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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
  SUBSTANTIALLY EQUIVALENT 1
GASTRO CONCEPTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOBAND SURGICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL CARE (WUHAN) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 3 3
2023 6 6
2025 3 3
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 8 8
Patient-Device Incompatibility 6 6
Unintended Movement 4 4
Activation, Positioning or Separation Problem 1 1
Defective Device 1 1
Retraction Problem 1 1
No Apparent Adverse Event 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18

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