K212166 is an FDA 510(k) clearance for the ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on January 7, 2022, 179 days after receiving the submission on July 12, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K212166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF - Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |