510(k) K171347

Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection by Xeridiem Medical Devices — Product Code PIF

K171347 is an FDA 510(k) premarket notification submitted by Xeridiem Medical Devices for the device "Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection". The FDA issued a decision of Substantially Equivalent on Jun 6, 2017. 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 has 2 other 510(k) clearances on record.