FDA 510(k)

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

K-Number: K240297 · 2024-05-03

Decision Date2024-05-03

Product CodeOAB

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) is a medical device manufactured by Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2024-05-03 under approval 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. It is manufactured by Us Medical Innovations, LLC. The 510(k) number is K240297.

When was Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) approved by the FDA?

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

What company makes Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)?

Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) is manufactured by Us Medical Innovations, LLC.

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.

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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.