FLASH EVD System (10-0002) is an AI-enabled medical device from 7D Surgical ULC, listed by FDA (510(k), K242480) with a decision date of 2024-12-27. Review panel: Neurology.
| FDA submission number | K242480 |
|---|---|
| Pathway | 510(k) |
| Company | 7D Surgical ULC |
| Review panel (specialty) | Neurology |
| FDA decision date | 2024-12-27 |
| Decision | Substantially Equivalent |
| Product code | HAW |
| Classification | Neurological Stereotaxic Instrument |
| Device class | 2 |
| Regulation number | 882.4560 |
| Review time (calendar days) | 128 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.