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510(k) Data Aggregation
K Number
K984255Device Name
OLYMPUS HX-20 SERIES LIGATING DEVICE
Manufacturer
Date Cleared
1999-01-12
(43 days)
Product Code
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS CORP OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Olympus HX-20-1 Endoscopic Ligator "EndoLoop" has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Ligation Loop(Standard) or MAJ-340 Ligation Loop (Small) designed to prevent or control bleeding following polypectompy of pedunculated polyps.
Device Description
The Olympus HX-20-1 Endoscopic Ligator is intended to deliver a MAJ-254 Ligation Loop (Standard) or MAJ-340 Ligation Loop (Small ) to prevent or control bleeding following polypectomy of pedunculated polyps. The Olympus HX-20-1 Endoscopic Ligator "EndoLoop" is substantially equivalent in intended use to the Olympus HX-20-1 which has been cleared premarket notification with #K964661. The modification on this submission differs from previously cleared 510(k) HX-20-1 in the instruction manual with emergency treatments and warnings.
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