Clearance Summary
evoDrill Cranial Perforator received FDA 510(k) clearance under submission number K231403, sponsored by Evonos GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-03-06.
- Submission: K231403
- Applicant / Sponsor: Evonos GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4305
- Decision date: 2024-03-06
Classification & Regulation
This clearance is catalogued under FDA product code HBF and 21 CFR 882.4305, within the Neurology review panel as a Class II device.