Clearance Summary
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection received FDA 510(k) clearance under submission number K171347, sponsored by Xeridiem Medical Devices. 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 2017-06-06.
- Submission: K171347
- Applicant / Sponsor: Xeridiem Medical Devices
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2017-06-06
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.