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FDA 510(k)

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

K-Number: K212166 · 2022-01-07

ApplicantInomed Medizintechnik GmbH
Decision Date2022-01-07
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is a medical device manufactured by Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-01-07 under approval number K212166. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Inomed Medizintechnik GmbH. The 510(k) number is K212166.

When was ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress approved by the FDA?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress received FDA 510(k) clearance on 2022-01-07, under approval number K212166.

What company makes ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is manufactured by Inomed Medizintechnik GmbH.

What is the FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

The FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is GWF.

Other Devices by Inomed Medizintechnik GmbH

K152505C2 NerveMonitor System K212164Mapping Suction Probe K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K223254C2 Xplore K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

Related Devices (Code: GWF)

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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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