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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic morcellator gastroenterology
Definition For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)
Product CodePTE
Regulation Number 884.1690
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERSCOPE, INC
  SUBSTANTIALLY EQUIVALENT 1
INTERSCOPE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 4 4
Fibrosis 1 1
Hematemesis 1 1
Dysphagia/ Odynophagia 1 1

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