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FDA 510(k)

ALARA Neuro Access Kit

K-Number: K190163 · 2019-07-16

ApplicantSurGenTec, LLC
Decision Date2019-07-16
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ALARA Neuro Access 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 2019-07-16 under 510(k) number K190163. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALARA Neuro Access Kit?

ALARA Neuro Access Kit is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is SurGenTec, LLC. The 510(k) number is K190163.

When did ALARA Neuro Access Kit receive FDA 510(k) clearance?

ALARA Neuro Access Kit received FDA 510(k) clearance on 2019-07-16, under 510(k) number K190163.

Who is the listed applicant for ALARA Neuro Access 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 Neuro Access Kit?

The FDA product code for ALARA Neuro Access Kit is PDQ.

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Related Devices (Code: PDQ)

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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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