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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic pancreatic debridement device
Regulation Description Endoscopic pancreatic debridement device.
Definition An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.
Product CodeQNE
Regulation Number 876.4330
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERSCOPE, INC
  GRANTED 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pancreatitis 1 1

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