K241458 is an FDA 510(k) clearance for the Borvo EVAC System (Ergo). This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Borvo Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 20, 2024, 89 days after receiving the submission on May 23, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K241458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2024 |
| Decision Date | August 20, 2024 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXG - Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |