FDA 510(k)

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

Número K: K240297 · 2024-05-03

Data da decisão2024-05-03

Código do produtoOAB

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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