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FDA 510(k)

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

K-Number: K240297 · 2024-05-03

ApplicantUs Medical Innovations, LLC
Decision Date2024-05-03
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K240297. 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 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K240297.

When did Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) receive FDA 510(k) clearance?

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) received FDA 510(k) clearance on 2024-05-03, under 510(k) number K240297.

Who is the listed applicant for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

The FDA 510(k) record lists Us Medical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

The FDA product code for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is OAB.

Other records listing Us Medical Innovations, LLC 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.

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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.K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.

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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