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FDA 510(k)

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

K-Number: K212871 · 2022-06-17

ApplicantGalvanize Therapeutics, Inc.
Decision Date2022-06-17
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode is a medical device manufactured by Galvanize Therapeutics, Inc.. It received FDA 510(k) clearance on 2022-06-17 under approval number K212871. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Galvanize Therapeutics, Inc.. The 510(k) number is K212871.

When was Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode approved by the FDA?

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

What company makes 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 manufactured by Galvanize Therapeutics, Inc..

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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Other Devices by Galvanize Therapeutics, Inc.

K233884INUMI™ Flex Needle K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle

Related Devices (Code: OAB)

K183385NanoKnife SystemAngiodynamics K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd. 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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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