Clearance Summary
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes received FDA 510(k) clearance under submission number K152984, sponsored by Bio Protech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2016-06-03.
- Submission: K152984
- Applicant / Sponsor: Bio Protech, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1385
- Decision date: 2016-06-03
Classification & Regulation
This clearance is catalogued under FDA product code IKT and 21 CFR 890.1385, within the Physical Medicine review panel as a Class II device.