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 a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2019-07-16 under approval 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. It is manufactured by SurGenTec, LLC. The 510(k) number is K190163.
When was ALARA Neuro Access Kit approved by the FDA?
ALARA Neuro Access Kit received FDA 510(k) clearance on 2019-07-16, under approval number K190163.
What company makes ALARA Neuro Access Kit?
ALARA Neuro Access Kit is manufactured by SurGenTec, LLC.
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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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.