510(k) K243152

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device by Applied Medical Resources Corp. — Product Code HEW

K243152 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corp. for the device "GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. Applied Medical Resources Corp. has at least 10 other 510(k) clearances on record.