Medical Device Manufacturer · CN , Shenzhen

Shenzhen HugeMed Medical Technical Development Co., Ltd. - FDA 510(k)...

8 submissions · 8 cleared · Since 2023

Recent clearances: Suction Pump (SU-90), Single-use Ureteral Access Sheath, Biliary Pancreaticobiliary Scope System

8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Shenzhen HugeMed Medical Technical Development Co., Ltd. Gastroenterology & Urology ✕

5 devices
1-5 of 5
Cleared Jul 08, 2025
Single-use Ureteral Access Sheath
K250695 · FED
Gastroenterology & Urology · 123d
Cleared Jan 21, 2025
Biliary Pancreaticobiliary Scope System
K241444 · FBN
Gastroenterology & Urology · 244d
Cleared May 10, 2024
Ureterorenoscope System
K240374 · FGB
Gastroenterology & Urology · 93d
Cleared Mar 06, 2024
Choledochoscope System
K231497 · FBN
Gastroenterology & Urology · 287d
Cleared Nov 13, 2023
Cystoscope System
K231118 · FAJ
Gastroenterology & Urology · 207d
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All8 Gastroenterology & Urology 5 Ear, Nose, Throat 2 General & Plastic Surgery 1