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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K253826
Device Name Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle
Applicant
Galvanize Therapeutics, Inc.
3200 Bridge Pkwy.
Redwood City,  CA  94065
Applicant Contact Deborah Sheffield
Correspondent
Galvanize Therapeutics, Inc.
3200 Bridge Pkwy.
Redwood City,  CA  94065
Correspondent Contact Elodie Trouche
Regulation Number878.4400
Classification Product Code
OAB  
Subsequent Product Code
GEI  
Date Received12/01/2025
Decision Date 05/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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