Clearance Summary
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE received FDA 510(k) clearance under submission number K012147, sponsored by Zevex, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-11-02.
- Submission: K012147
- Applicant / Sponsor: Zevex, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2001-11-02
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.