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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K252831

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) · Dolanvy (Suzhou) Medical Technology Co., Ltd. · decided 2026-04-28 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
DLRDLR-8924Dolanvy (Suzhou) Medical Technology Co.,Ltd.KPI06975854030050
DLRDLR-8921Dolanvy (Suzhou) Medical Technology Co.,Ltd.KPI06975854030029
DLRDLR-8923Dolanvy (Suzhou) Medical Technology Co.,Ltd.KPI06975854030043
DLRDLR-8927Dolanvy (Suzhou) Medical Technology Co.,Ltd.KPI06975854030081
DLRDLR-8925Dolanvy (Suzhou) Medical Technology Co.,Ltd.KPI06975854030067
DLRDLR-8926Dolanvy (Suzhou) Medical Technology Co.,Ltd.KPI06975854030074
DLRDLR-8922Dolanvy (Suzhou) Medical Technology Co.,Ltd.KPI06975854030036