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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscopic accessories, esophageal sizing
Definition To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.
Product CodeQJN
Regulation Number 876.5360
Device Class 2


Premarket Reviews
ManufacturerDecision
TORAX MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TORAX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Erosion 1 1
Nonstandard Device 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 2 2
Nausea 1 1
Dysphasia 1 1
Hematemesis 1 1
Erosion 1 1
Hemorrhage/Bleeding 1 1

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