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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessory, assisted reproduction
Regulation Description Assisted reproduction accessories.
Product CodeMQG
Regulation Number 884.6120
Device Class 2


Premarket Reviews
ManufacturerDecision
HUA YUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN HUCHUANG UNION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 3 3
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 2 2
Material Frayed 1 1
Material Split, Cut or Torn 1 1
Off-Label Use 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Medical Llc II Jan-12-2024
2 Cook Medical Llc II Jan-08-2021
3 CooperSurgical, Inc. II Sep-28-2022
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