Resection Electrodes

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.

Pre-market Notification Details

Device IDK152092
510k NumberK152092
Device Name:Resection Electrodes
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant Olympus Winter & Ibe GmbH Kuehnstrasse 61 Hamburg,  DE 22045
ContactKatharina Schnackenburg
CorrespondentGraham Baillie
GYRUS ACMI, INC. 136 TURNPIKE RD. 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 Received2015-07-28
Decision Date2015-10-26
Summary:summary

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