Clearance Summary
Anchor Bolt (as an accessory to Depth Electrodes) received FDA 510(k) clearance under submission number K181544, 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 2018-08-09.
- Submission: K181544
- Applicant / Sponsor: Ad-Tech Medical Instrument Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1330
- Decision date: 2018-08-09
Classification & Regulation
This clearance is catalogued under FDA product code GZL and 21 CFR 882.1330, within the Neurology review panel as a Class II device.