About This 510(k) Submission
K243152 is an FDA 510(k) clearance for the GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device, a Culdoscope (and Accessories) (Class II — Special Controls, product code HEW), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on October 2, 2025, 367 days after receiving the submission on September 30, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1640.