Clearance Summary
EasyPass Guidewire received FDA 510(k) clearance under submission number K153264, sponsored by Medi-Globe Corporation. 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 2016-05-19.
- Submission: K153264
- Applicant / Sponsor: Medi-Globe Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-05-19
Classification & Regulation
This clearance is catalogued under FDA product code OCY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.