K242480
- 510(k) number
- K242480
- Device name
- FLASH EVD System (10-0002)
- Applicant
- 7D Surgical ULC CA
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2024-12-27
- Date received
- 2024-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242480.pdf
Official FDA record: K242480
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.