Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

Low Energy Direct Current Thermal Ablation System

Galvanize Therapeutics, Inc.

The following data is part of a premarket notification filed by Galvanize Therapeutics, Inc. with the FDA for Aliya(tm) System, Aliya(tm) Generator, Aliya(tm) Needle, Aliya(tm) Electrode.

Pre-market Notification Details

Device IDK212871
510k NumberK212871
Device Name:Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
ClassificationLow Energy Direct Current Thermal Ablation System
Applicant Galvanize Therapeutics, Inc. 1531 Industrial Road San Carlos,  CA  94070
ContactDeborah Sheffield
CorrespondentLisa L. Pritchard
DuVal & Assoicates, P.A. 1820 Medical Arts Building 825 Nicollet Mall Minneapolis,  MN  55402
Product CodeOAB  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-09
Decision Date2022-06-17

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.