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510(k) Data Aggregation
K Number
K012685Device Name
REPROCESSED ENDOSCOPIC ELECTRODES
Manufacturer
Date Cleared
2002-02-14
(184 days)
Regulation Number
876.4300Why did this record match?
Product Code :
NLW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.
Device Description
Reprocessed endoscopic electrodes are electrosurgical electrode devices that have a wide variety of tip configurations and sizes. The device is used to cut and cauterize prostate, bladder, gynecological, and urological tissue. They are used in conjunction with an endoscope and are powered by a separate RF generator. The RF generator component is not included in this submission; only the endoscopic electrodes are reprocessed.
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