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FDA 510(k)

INUMI™ Flex Needle

K-Number: K233884 · 2024-05-22

ApplicantGalvanize Therapeutics, Inc.
Decision Date2024-05-22
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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 2024-05-22 under 510(k) number K233884. 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 INUMI™ Flex Needle?

INUMI™ Flex Needle is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Galvanize Therapeutics, Inc.. The 510(k) number is K233884.

When did INUMI™ Flex Needle receive FDA 510(k) clearance?

INUMI™ Flex Needle received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233884.

Who is the listed applicant for 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 INUMI™ Flex Needle?

The FDA product code for INUMI™ Flex Needle is OAB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05851430Galvanize Prospective/Retrospective Pulsed Electric Field Device RegistryRECRUITING

Other records listing Galvanize Therapeutics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleK212871Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

Related Devices (Code: OAB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.K253198NanoKnife Generator (H78720300351US0)AngiodynamicsK242687NanoKnife 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.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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