Clearance Summary
Y2K2 ENTERNAL TUBE FLUID FILTER received FDA 510(k) clearance under submission number K051206, sponsored by Moss Medical 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 2005-11-02.
- Submission: K051206
- Applicant / Sponsor: Moss Medical Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2005-11-02
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.