Cleared Traditional

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

K212871 · Galvanize Therapeutics, Inc. · General & Plastic Surgery

Jun 2022

Decision

281d

Days

Class 2

Risk

About This 510(k) Submission

K212871 is an FDA 510(k) clearance for the Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode, a Low Energy Direct Current Thermal Ablation System (Class II — Special Controls, product code OAB), submitted by Galvanize Therapeutics, Inc. (San Carlos, US). The FDA issued a Cleared decision on June 17, 2022, 281 days after receiving the submission on September 9, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K212871 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2021
Decision Date	June 17, 2022
Days to Decision	281 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OAB — Low Energy Direct Current Thermal Ablation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Ablation Of Soft Tissue