Clearance Summary
OSMONICS SOLUTION DELIVERY SYSTEM received FDA 510(k) clearance under submission number K023011, sponsored by Osmonics Medical Systems. 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 2003-06-26.
- Submission: K023011
- Applicant / Sponsor: Osmonics Medical Systems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2003-06-26
Classification & Regulation
This clearance is catalogued under FDA product code FIN and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.