Clearance Summary
NUTRISAFE ENTERAL FEEDING TUBE received FDA 510(k) clearance under submission number K981629, sponsored by Schiff & Co.. 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 1999-02-04.
- Submission: K981629
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1999-02-04
Classification & Regulation
This clearance is catalogued under FDA product code FPD and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.