FDA 510(k)

SpydrBlade Flex Instrument (PRD-RG1-001)

Número K: K242774 · 2025-06-06

Data da decisão2025-06-06

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpydrBlade Flex Instrument (PRD-RG1-001) 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 2025-06-06 under 510(k) number K242774. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SpydrBlade Flex Instrument (PRD-RG1-001)?

SpydrBlade Flex Instrument (PRD-RG1-001) is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K242774.

When did SpydrBlade Flex Instrument (PRD-RG1-001) receive FDA 510(k) clearance?

SpydrBlade Flex Instrument (PRD-RG1-001) received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242774.

Who is the listed applicant for SpydrBlade Flex Instrument (PRD-RG1-001)?

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 SpydrBlade Flex Instrument (PRD-RG1-001)?

The FDA product code for SpydrBlade Flex Instrument (PRD-RG1-001) is KNS.

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Fonte oficial

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