About This 510(k) Submission
K232046 is an FDA 510(k) clearance for the Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Xeridiem Medical Devices, A Spectrum Plastics Group Company (Tucson, US). The FDA issued a Cleared decision on October 6, 2023, 88 days after receiving the submission on July 10, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.