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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)
Product CodeHHK
Regulation Number 884.1175
Device Class 2


Premarket Reviews
ManufacturerDecision
CROSSBAY MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 4 4
2021 1 1
2022 2 2
2023 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 4 4
Detachment of Device or Device Component 2 2
Physical Resistance/Sticking 2 2
Break 2 2
Decrease in Suction 2 2
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Hemorrhage/Bleeding 2 2
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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