K172035 is an FDA 510(k) clearance for the EKOS ultrasound EVD Device, EVD Control Unit. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Btg International, Inc. (Bothell, US). The FDA issued a Cleared decision on March 24, 2018, 262 days after receiving the submission on July 5, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K172035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2017 |
| Decision Date | March 24, 2018 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | JXG - Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |