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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscopic single port access device
Definition A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Product CodeOTJ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AFS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
DALIM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 1 1
Structural Problem 1 1
Connection Problem 1 1
Material Integrity Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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