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

Clearance record K201121

Sphincterotome · Hangzhou AGS MedTech Co., Ltd. · decided 2021-02-05 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
(unnamed)AG-5099-05Hangzhou AGS MedTech Co., Ltd.KNS06959664912126
(unnamed)AG-5098-0525Hangzhou AGS MedTech Co., Ltd.KNS06959664912058