Clearance Summary
ENDOSOPIC STENE MANIPULATING BALLOON received FDA 510(k) clearance under submission number K850489, sponsored by Mill-Rose Laboratory. 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 1985-04-22.
- Submission: K850489
- Applicant / Sponsor: Mill-Rose Laboratory
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1985-04-22
Classification & Regulation
This clearance is catalogued under FDA product code LQR and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.