Clearance Summary
GYRUS AMCI PK BUTTON ELECTRODE received FDA 510(k) clearance under submission number K120567, sponsored by Gyrus Acmi, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-06-20.
- Submission: K120567
- Applicant / Sponsor: Gyrus Acmi, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2012-06-20
Classification & Regulation
This clearance is catalogued under FDA product code FAS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.