ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress— 510(k) K263010
Substantially Equivalentinomed Medizintechnik GmbH
FDA 510(k) clearance K263010 for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress, Substantially Equivalent on 2026-09-24. Applicant: inomed Medizintechnik GmbH. Device class: 2.
Summary
inomed Medizintechnik GmbH cleared several ISIS products together: ISIS Headboxes, the ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, and ISIS Xpress. They're filed under GWF, evoked response electrical stimulators. The record doesn't describe what each product does.
Class II, 21 CFR 882.1870, Neurology panel. inomed filed it as a Special 510(k).
inomed filed from Emmendingen, Germany. Review took 27 days (August 28 to September 24, 2026).
Clearance details
- Applicant
- inomed Medizintechnik GmbH
- Product code
- Product code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Emmendingen, DE
Recent devices under product code GWF
view allMore clearances from inomed Medizintechnik GmbH
view all- K242852 — ALM 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)
- K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- K223254 — C2 Xplore
- K212164 — Mapping Suction Probe
- K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.