FDA 510(k)

ABI Instrumento, Sistema de Electrosurgia Creo

Número K: K200298 · 2021-01-05

Data da decisão2021-01-05

Código do produtoNEY

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ABI 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 2021-01-05 under 510(k) number K200298. 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 ABI Instrument, Creo Electrosurgical System?

ABI Instrument, Creo Electrosurgical System is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K200298.

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

ABI Instrument, Creo Electrosurgical System received FDA 510(k) clearance on 2021-01-05, under 510(k) number K200298.

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

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

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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 K223138Instrumento Electrosurgical AB1, Sistema Electrosurgical Creo K221672Creo Electrosurgical System with NP1 Instrument

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Fonte oficial

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