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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

MDR Year MDR Reports MDR Events
2022 1 1
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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