FDA 510(k)

Kit de Acesso Neuro de ALARA BMA (ALARA BMAN e ALARA BMAC Kit)

Número K: K240664 · 2024-08-09

Data da decisão2024-08-09

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K240664. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)?

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is SurGenTec, LLC. The 510(k) number is K240664.

When did ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) receive FDA 510(k) clearance?

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) received FDA 510(k) clearance on 2024-08-09, under 510(k) number K240664.

Who is the listed applicant for ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)?

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

What is the FDA product code for ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)?

The FDA product code for ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is KNW.

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Fonte oficial

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