FDA 510(k)

Instrumento Electrosurgical AB1, Sistema Electrosurgical Creo

N.º K: K223138 · 2023-06-26

Fecha de decisión2023-06-26

Código de productoNEY

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AB1 Electrosurgical Instrument, Creo Electrosurgical System 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 2023-06-26 under 510(k) number K223138. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AB1 Electrosurgical Instrument, Creo Electrosurgical System?

AB1 Electrosurgical Instrument, Creo Electrosurgical System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K223138.

When did AB1 Electrosurgical Instrument, Creo Electrosurgical System receive FDA 510(k) clearance?

AB1 Electrosurgical Instrument, Creo Electrosurgical System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K223138.

Who is the listed applicant for AB1 Electrosurgical Instrument, Creo Electrosurgical System?

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 AB1 Electrosurgical Instrument, Creo Electrosurgical System?

The FDA product code for AB1 Electrosurgical Instrument, Creo Electrosurgical System is NEY.

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Otros registros que enlistan a Creo Medical, Ltd. como solicitante

K242774SpydrBlade Flex Instrument (PRD-RG1-001)K242983CROMA Electrosurgical Generator (PRD-EMR-050)K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)K230328Speedboat Flush SB1 Instrument K221672Creo Electrosurgical System with NP1 Instrument K200298ABI Instrumento, Sistema Electrosurgical Creo

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Fuente oficial

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