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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, biopsy, suction
Product CodeFCK
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 1 1
2022 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 2 2
Failure to Cut 2 2
Insufficient Information 1 1
Activation Failure 1 1
Suction Problem 1 1
Physical Resistance 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 4 4
Tissue Damage 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Syncope/Fainting 1 1
Insufficient Information 1 1

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