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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
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2017 2 2
2018 1 1
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 4 4
Break 3 3
Decrease in Suction 2 2
Material Fragmentation 2 2
Physical Resistance/Sticking 2 2
Device Operates Differently Than Expected 1 1
Entrapment of Device 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 5 5
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Hemorrhage/Bleeding 2 2
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 CooperSurgical, Inc. III Dec-01-2014
2 Instrumed International, Inc. II Dec-16-2014
3 Olympus Corporation of the Americas II Oct-12-2022
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