Clearance Summary
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE received FDA 510(k) clearance under submission number K151503, sponsored by Gbuk Enteral Limited. 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 2016-04-05.
- Submission: K151503
- Applicant / Sponsor: Gbuk Enteral Limited
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2016-04-05
Classification & Regulation
This clearance is catalogued under FDA product code PIF and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.