FDA 510(k)

Creo Electrosurgical System with NP1 Instrument

Número K: K221672 · 2023-02-14

Data da decisão2023-02-14

Código do produtoNEY

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Creo Electrosurgical System with NP1 Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2023-02-14 under 510(k) number K221672. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Creo Electrosurgical System with NP1 Instrument?

Creo Electrosurgical System with NP1 Instrument is a medical device that received FDA 510(k) clearance on 2023-02-14. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K221672.

When did Creo Electrosurgical System with NP1 Instrument receive FDA 510(k) clearance?

Creo Electrosurgical System with NP1 Instrument received FDA 510(k) clearance on 2023-02-14, under 510(k) number K221672.

Who is the listed applicant for Creo Electrosurgical System with NP1 Instrument?

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

What is the FDA product code for Creo Electrosurgical System with NP1 Instrument?

The FDA product code for Creo Electrosurgical System with NP1 Instrument is NEY.

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