StrataMR guider tool
K-Number: K181622 · 2018-10-01
ApplicantMedtronic Neurosurgery
Decision Date2018-10-01
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
StrataMR guider tool is a medical device manufactured by Medtronic Neurosurgery. It received FDA 510(k) clearance on 2018-10-01 under approval number K181622. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the StrataMR guider tool?
StrataMR guider tool is a medical device that received FDA 510(k) clearance on 2018-10-01. It is manufactured by Medtronic Neurosurgery. The 510(k) number is K181622.
When was StrataMR guider tool approved by the FDA?
StrataMR guider tool received FDA 510(k) clearance on 2018-10-01, under approval number K181622.
What company makes StrataMR guider tool?
StrataMR guider tool is manufactured by Medtronic Neurosurgery.
What is the FDA product code for StrataMR guider tool?
The FDA product code for StrataMR guider tool is JXG.
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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.