510(k) clearance

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

FDA 510(k) source

510(k) number

K263010

Applicant

inomed Medizintechnik GmbH

Decision date

Sep 24, 2026

Date received

Aug 28, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

GWF

Device type

Stimulator, Electrical, Evoked Response

Device class

Class II

Regulation

21 CFR 882.1870

Advisory committee

Neurology

Statement or summary

Summary

Third party

N

Location

Emmendingen, DE