Clearance Summary
ACHELASIA BALLOON DIALATOR received FDA 510(k) clearance under submission number K884715, sponsored by Primrose Medical, 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 1989-09-29.
- Submission: K884715
- Applicant / Sponsor: Primrose Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 1989-09-29
Classification & Regulation
This clearance is catalogued under FDA product code KNQ and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.