K161715 is an FDA 510(k) clearance for the EndyGel. This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Endymed Medical, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on February 7, 2017, 231 days after receiving the submission on June 21, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K161715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2016 |
| Decision Date | February 07, 2017 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYB - Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |