FDA 510(k)

StrataMR guider tool

K-Number: K181622 · 2018-10-01

Decision Date2018-10-01

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

StrataMR guider tool is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2018-10-01 under 510(k) 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. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K181622.

When did StrataMR guider tool receive FDA 510(k) clearance?

StrataMR guider tool received FDA 510(k) clearance on 2018-10-01, under 510(k) number K181622.

Who is the listed applicant for StrataMR guider tool?

The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StrataMR guider tool?

The FDA product code for StrataMR guider tool is JXG.

Other records listing Medtronic Neurosurgery as applicant

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Official Source

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