FDA 510(k) Applications Submitted by Cathy Shi

FDA 510(k) Number Submission Date Device Name Applicant
K240374 02/07/2024 Ureterorenoscope System Shenzhen HugeMed Medical Technical Development Co., Ltd.
K250695 03/07/2025 Single-use Ureteral Access Sheath Shenzhen HugeMed Medical Technical Development Co., Ltd.
K241444 05/22/2024 Biliary Pancreaticobiliary Scope System Shenzhen HugeMed Medical Technical Development Co., Ltd.
K231497 05/24/2023 Choledochoscope System Shenzhen HugeMed Medical Technical Development Co., Ltd
K232435 08/14/2023 Rhinolaryngoscope system Shenzhen HugeMed Medical Technical Development Co., Ltd.


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