K231403
- 510(k) number
- K231403
- Device name
- evoDrill Cranial Perforator
- Applicant
- Evonos GmbH & Co. KG DE
- Product code
- HBF — Drills, Burrs, Trephines & Accessories (Compound, Po
- Decision date
- 2024-03-06
- Date received
- 2023-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K231403.pdf
Official FDA record: K231403
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.