Clearance Summary
ROSS EMBRACE PUMP SET received FDA 510(k) clearance under submission number K011467, sponsored by Ross Products. 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 2001-08-10.
- Submission: K011467
- Applicant / Sponsor: Ross Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2001-08-10
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.