510(k) K253826

Device: Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI? Flex Needle
Applicant: Galvanize Therapeutics, Inc.
510(k) number: K253826
Product code: OAB
Decision: Substantially Equivalent (SESE)
Decision date: 2026-05-07
Date received: 2025-12-01
Regulation: 878.4400
Classification name: Low Energy Direct Current Thermal Ablation System
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K253198	NanoKnife Generator (H78720300351US0)	Angiodynamics	2026-03-24
K242687	NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)	AngioDynamics, Inc.	2024-12-06
K240376	Electroporation System (N3000)	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	2024-10-04
K233884	INUMI™ Flex Needle	Galvanize Therapeutics, Inc.	2024-05-22
K240297	Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)	Us Medical Innovations, LLC	2024-05-03
K222001	Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe	Zhejiang Curaway Medical Technology Co., Ltd.	2023-06-08
K212871	Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode	Galvanize Therapeutics, Inc.	2022-06-17
K183385	NanoKnife System	Angiodynamics	2019-06-18
K150089	NanoKnife System	AngioDynamics, Inc.	2015-06-18
K102329	NANOKNIFE SYSTEM	AngioDynamics, Inc.	2011-10-24
K080202	ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT	Oncobionics, Inc.	2008-05-08
K080376	ONCOBIONIC SYSTEM	Oncobionic Incorporated	2008-04-02
K060054	ONCOBIONIC SYSTEM	Oncobionics, Inc.	2006-11-21