510(k) K232046

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection by Xeridiem Medical Devices, A Spectrum Plastics Group Company — Product Code PIF

K232046 is an FDA 510(k) premarket notification submitted by Xeridiem Medical Devices, A Spectrum Plastics Group Company for the device "Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection". The FDA issued a decision of Substantially Equivalent on October 6, 2023. 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.