Clearance Summary
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit received FDA 510(k) clearance under submission number K180708, sponsored by Xeridiem Medical Devices, A Spectrum Plastics Group Company. 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 2018-10-18.
- Submission: K180708
- Applicant / Sponsor: Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2018-10-18
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.