K201678 is an FDA 510(k) clearance for the iCE-SG Subcutaneous Electrode Arrays. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Ice Neurosystems, Inc. (Washington, US). The FDA issued a Cleared decision on March 8, 2021, 262 days after receiving the submission on June 19, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K201678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2020 |
| Decision Date | March 08, 2021 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |