Clearance Summary
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR received FDA 510(k) clearance under submission number K050232, sponsored by Boston Scientific Corp. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2005-03-11.
- Submission: K050232
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2005-03-11
Classification & Regulation
This clearance is catalogued under FDA product code PID and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.