FDA 510(k)

Speedboat Flush SB1 Instrument

N.º K: K230328 · 2023-10-31

Fecha de decisión2023-10-31

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Speedboat Flush SB1 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 2023-10-31 under 510(k) number K230328. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Speedboat Flush SB1 Instrument?

Speedboat Flush SB1 Instrument is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K230328.

When did Speedboat Flush SB1 Instrument receive FDA 510(k) clearance?

Speedboat Flush SB1 Instrument received FDA 510(k) clearance on 2023-10-31, under 510(k) number K230328.

Who is the listed applicant for Speedboat Flush SB1 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 Speedboat Flush SB1 Instrument?

The FDA product code for Speedboat Flush SB1 Instrument is KNS.

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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)K223138Instrumento Electrosurgical AB1, Sistema Electrosurgical Creo K221672Creo Electrosurgical System with NP1 Instrument K200298ABI Instrumento, Sistema Electrosurgical Creo

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Dispositivos relacionados (Código: KNS)

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Fuente oficial

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