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510(k) Data Aggregation
K Number
K974515Device Name
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
Manufacturer
Date Cleared
1997-12-22
(20 days)
Product Code
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
ENDOLAP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Endolap Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrical generator cleared for medical use. The Endolap Resectoscope roller electrode device is indicated for ablation and coagulation of the soft tissue and is intended for use with compatible resectoscopes.
Device Description
The Endolap Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrical generator cleared for medical use.
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K Number
K974516Device Name
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
Manufacturer
Date Cleared
1997-12-22
(20 days)
Product Code
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
ENDOLAP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Endolap Resectoscope Cutting Loop Device is a momopolar electrode designed to deliver radiofrequency energy that is supplied by and electrical generator cleared for medical use. The Endolap Resectoscope Cutting Loop device is inicated for ablation and coagulation of the soft tissue and is intlended for use with compatlible resectoscopes,
Device Description
Resectoscope Cutting Loop
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