Clearance Summary
EsoFLIP® ES-310 Balloon Catheter received FDA 510(k) clearance under submission number K172128, sponsored by Crospon, Ltd.. 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 2017-11-22.
- Submission: K172128
- Applicant / Sponsor: Crospon, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2017-11-22
Classification & Regulation
This clearance is catalogued under FDA product code PIE and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.