Resection Electrodes

Electrode, Electrosurgical

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.

Pre-market Notification Details

Device IDK161600
510k NumberK161600
Device Name:Resection Electrodes
ClassificationElectrode, Electrosurgical
Applicant OLYMPUS WINTER & IBE GMBH KUEHNSTRASSE 61 Hamburg,  DE 22045
ContactKatharina Campbell
CorrespondentDolan Mills
GYRUS ACMI, INC. 136 TURNPIKE ROAD Southborough,  MA  01772
Product CodeJOS  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-09
Decision Date2016-09-06
Summary:summary

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