FDA 510(k)

Sistema Aliya™, Gerador Aliya™, Agulha Aliya™, Eletródo Aliya™

Número K: K212871 · 2022-06-17

Data da decisão2022-06-17

Código do produtoOAB

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode 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 2022-06-17 under 510(k) number K212871. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode?

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Galvanize Therapeutics, Inc.. The 510(k) number is K212871.

When did Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode receive FDA 510(k) clearance?

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode received FDA 510(k) clearance on 2022-06-17, under 510(k) number K212871.

Who is the listed applicant for Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode?

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

The FDA product code for Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode is OAB.

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Outros registros que listam Galvanize Therapeutics, Inc. como candidato(a)

K253826Sistema Aliya® EX; Gerador Aliya® EX; Agulha Aliya®; Eletródo Aliya®; Agulha Flex INUMI™K233884INUMI™ Flex Needle

Dispositivos Relacionados (Código: 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.K253826Sistema Aliya® EX; Gerador Aliya® EX; Agulha Aliya®; Eletródo Aliya®; Agulha Flex INUMI™Galvanize Therapeutics, Inc.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.

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