Clearance Summary
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter received FDA 510(k) clearance under submission number K143609, sponsored by Olympus Surgical Technologies America. 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 2015-03-27.
- Submission: K143609
- Applicant / Sponsor: Olympus Surgical Technologies America
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2015-03-27
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.