510(k) K180708

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 by Xeridiem Medical Devices, A Spectrum Plastics Group Company — Product Code PIF

K180708 is an FDA 510(k) premarket notification submitted by Xeridiem Medical Devices, A Spectrum Plastics Group Company for the device "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". The FDA issued a decision of Substantially Equivalent (kit) on October 18, 2018. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Xeridiem Medical Devices, A Spectrum Plastics Group Company has at least 1 other 510(k) clearance on record.