FDA 510(k)

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle

K-Nummer: K253826 · 2026-05-07

AntragstellerGalvanize Therapeutics, Inc.

Entscheidungsdatum2026-05-07

ProduktcodeOAB

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is the device name listed in this FDA 510(k) record. The listed applicant is Galvanize Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K253826. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Galvanize Therapeutics, Inc.. The 510(k) number is K253826.

When did Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle receive FDA 510(k) clearance?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253826.

Who is the listed applicant for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

The FDA 510(k) record lists Galvanize Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

The FDA product code for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is OAB.

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Weitere Einträge mit Galvanize Therapeutics, Inc. als Antragsteller

K233884INUMI™ Flex Needle K212871Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Nadel, Aliya(TM) Elektrode

Verwandte Geräte (Code: OAB)

K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)Hangzhou Ruidi Biotechnology , Ltd.K253198NanoKnife Generator (H78720300351US0)Angiodynamics K242687NanoKnife 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.K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC

Offizielle Quelle

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