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FDA 510(k)

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

K-Number: K243945 · 2025-04-24

ApplicantSurGenTec, LLC
Decision Date2025-04-24
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2025-04-24 under approval number K243945. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by SurGenTec, LLC. The 510(k) number is K243945.

When was ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) approved by the FDA?

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) received FDA 510(k) clearance on 2025-04-24, under approval number K243945.

What company makes ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)?

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is manufactured by SurGenTec, LLC.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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