About This 510(k) Submission
K180708 is an FDA 510(k) clearance for the 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, 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 18, 2018, 213 days after receiving the submission on March 19, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.