FDA 510(k)

KIT DE ACCESO NEURO ALARA BMA (KIT ALARA BMAN y ALARA BMAC)

N.º K: K243945 · 2025-04-24

Fecha de decisión2025-04-24

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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 2025-04-24 under 510(k) number K243945. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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 2025-04-24. The listed applicant is SurGenTec, LLC. The 510(k) number is K243945.

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 2025-04-24, under 510(k) number K243945.

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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Fuente oficial

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