Medical Device Manufacturer · CN , Shenzhen

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

7 submissions · 7 cleared · Since 2023
7
Total
7
Cleared
0
Denied

Shenzhen HugeMed Medical Technical Development Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.

Latest FDA clearance: Jul 2025. Active since 2023. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Shenzhen Chonconn Medical Device Consulting Co., Ltd. and Shenzhen Chonconn Medical Consulting Co., Ltd..

FDA 510(k) Regulatory Record - Shenzhen HugeMed Medical Technical Development Co., Ltd.
7 devices
1-7 of 7
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 Apr 26, 2024
Rhinolaryngoscope system
K232435 · EOB
Ear, Nose, Throat · 256d
Cleared Mar 06, 2024
Choledochoscope System
K231497 · FBN
Gastroenterology & Urology · 287d
Cleared Nov 13, 2023
Cystoscope System
K231118 · FAJ
Gastroenterology & Urology · 207d
Cleared Apr 11, 2023
Bronchoscope System
K222910 · EOQ
Ear, Nose, Throat · 197d
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All7 Gastroenterology & Urology 5 Ear, Nose, Throat 2