FDA 510(k), K212871, Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

510(K) Number: K212871
Device Name: Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
Manufacturer: Galvanize Therapeutics, Inc.
Device Classification Name: Low Energy Direct Current Thermal Ablation System
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 09/09/2021
Decision Date: 06/17/2022
Regulation Medical Specialty: General & Plastic Surgery

• Total Pages: 8,975
• Fully Redacted Pages: 7,750
• Content Pages: 1,225 (Total pages minus fully redacted pages)