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FDA 510(k)

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM

K-Number: K091457 · 2009-12-08

ApplicantNexstim OY
Decision Date2009-12-08
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nexstim OY. It received FDA 510(k) clearance on 2009-12-08 under 510(k) number K091457. 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 NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM?

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-08. The listed applicant is Nexstim OY. The 510(k) number is K091457.

When did NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM receive FDA 510(k) clearance?

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM received FDA 510(k) clearance on 2009-12-08, under 510(k) number K091457.

Who is the listed applicant for NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM?

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

What is the FDA product code for NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM?

The FDA product code for NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM is GWF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Nexstim OY as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112881NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

Related Devices (Code: GWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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.

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