Clearance Summary
Cranial Drill Bits and Accessories received FDA 510(k) clearance under submission number K170442, sponsored by Ad-Tech Medical Instrument Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-09-07.
- Submission: K170442
- Applicant / Sponsor: Ad-Tech Medical Instrument Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 2017-09-07
Classification & Regulation
This clearance is catalogued under FDA product code HBE and 21 CFR 882.4310, within the Neurology review panel as a Class II device.