We are pleased to announce that Cultiv8 Medical was notified by the U.S. Food and Drug Administration on January 22, 2026 that they had completed their review of the Genie Max submission and have granted 510(k) clearance. Genie Max is a large-bore, hemostatic introducer sheath used in some of the most challenging minimally invasive medical procedures. Genie Max was designed to easily navigate difficult anatomy, provide complete hemostasis and improve workflow with the “set it and forget it” valve design. The Genie Max portfolio comes in diameters ranging from 10-26Fr and lengths of 15,33,45 and 65 cm. Bob Atkinson, Managing Director of Cultiv8 Medical said, “This 510(k) clearance is an important milestone for the company and the entire Genie Vascular portfolio. In addition to Genie Max, the company is also developing two products that leverage our proprietary, expandable sheath design. Genie eMax is an expandable, large-bore introducer sheath used primarily in structural heart procedures and Genie GX Tracker is an expandable guide extension catheter used to navigate difficult anatomy encountered during PCIs. We look forward to bringing all our novel technologies to clinicians around the world.”
