Clearance Summary
Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter received FDA 510(k) clearance under submission number K180086, 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 2018-03-08.
- Submission: K180086
- Applicant / Sponsor: Gyrus Acmi, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2018-03-08
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.