Resection Electrodes With HF Cable

Electrode, Electrosurgical, Active, Urological

Olympus Winter & Ibe GmbH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Resection Electrodes With Hf Cable.

Pre-market Notification Details

Device IDK171965
510k NumberK171965
Device Name:Resection Electrodes With HF Cable
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant Olympus Winter & Ibe GmbH Kuehnstrasse 61 Hamburg,  DE 22045
ContactJan-oliver Upmeier
CorrespondentDolan Mills
Gyrus ACMI, Inc. 136 Turnpike Road Southborough,  MA  01772
Product CodeFAS  
Subsequent Product CodeFJL
Subsequent Product CodeHIH
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-30
Decision Date2017-09-28
Summary:summary

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