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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device curette, suction, endometrial (and accessories)
Regulation Description Endometrial suction curette and accessories.
Product CodeHHK
Regulation Number 884.1175
Device Class 2


Premarket Reviews
ManufacturerDecision
CROSSBAY MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
GCMEDICA ENTERPRISE LTD.(WUXI)
  SUBSTANTIALLY EQUIVALENT 1
LI MEDICAL CORPORATION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 1 1
2024 4 4
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 5 5
Detachment of Device or Device Component 4 4
Break 2 2
Physical Resistance/Sticking 2 2
Decrease in Suction 2 2
Entrapment of Device 1 1
Communication or Transmission Problem 1 1
Use of Device Problem 1 1
Increase in Pressure 1 1
Suction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Foreign Body In Patient 2 2
Bacterial Infection 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Insufficient Information 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Oct-12-2022
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