Clearance Summary
U Deliver Bolink ENFit Enteral Feeding Sets received FDA 510(k) clearance under submission number K190310, sponsored by U Deliver Medical, LLC. 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 2019-05-31.
- Submission: K190310
- Applicant / Sponsor: U Deliver Medical, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2019-05-31
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.