Clearance Summary
ELECTRO-GEL received FDA 510(k) clearance under submission number K111717, sponsored by Electro-Cap Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-01-05.
- Submission: K111717
- Applicant / Sponsor: Electro-Cap Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 2012-01-05
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.