FDA 510(k)

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

K-Nummer: K263010 · 2026-09-24

Entscheidungsdatum2026-09-24

ProduktcodeGWF

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is the device name listed in this FDA 510(k) record. The listed applicant is inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K263010. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

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 2026-09-24. The listed applicant is inomed Medizintechnik GmbH. The 510(k) number is K263010.

When did ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress receive FDA 510(k) clearance?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress received FDA 510(k) clearance on 2026-09-24, under 510(k) number K263010.

Who is the listed applicant for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

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

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.

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Verwandte Geräte (Code: GWF)

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology Incorporated K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated K242345Delphi StimulatorQuantalx Neuroscience K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.

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