GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is an FDA 510(k)-cleared medical device (K243152) manufactured by Applied Medical Resources Corp.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2025. Regulation: 8.