Clearance Summary
ENTERAL FEEDING BAG, 1000 ML, & TUBING SET received FDA 510(k) clearance under submission number K851975, sponsored by Venusa , Ltd.. 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 1985-09-05.
- Submission: K851975
- Applicant / Sponsor: Venusa , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1985-09-05
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.