FDA 510(k)

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set

Número K: K202562 · 2020-11-02

Data da decisão2020-11-02

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set is the device name listed in this FDA 510(k) record. The listed applicant is Ellusa, LLC. It received FDA 510(k) clearance on 2020-11-02 under 510(k) number K202562. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set?

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set is a medical device that received FDA 510(k) clearance on 2020-11-02. The listed applicant is Ellusa, LLC. The 510(k) number is K202562.

When did Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set receive FDA 510(k) clearance?

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set received FDA 510(k) clearance on 2020-11-02, under 510(k) number K202562.

Who is the listed applicant for Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set?

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

What is the FDA product code for Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set?

The FDA product code for Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set is GEI.

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