Zhuhai Pusen Medical Technology Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Zhuhai Pusen Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250), Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH), Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R
7
Total
7
Cleared
0
Denied
Zhuhai Pusen Medical Technology Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Zhuhai, CN.
Latest FDA clearance: Apr 2026. Active since 2017. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Zhuhai Pusen Medical Technology Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Zhuhai Pusen Medical Technology Co., Ltd.
7 devices
Cleared
Apr 06, 2026
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050,...
Gastroenterology & Urology
48d
Cleared
Jul 16, 2024
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible...
Gastroenterology & Urology
232d
Cleared
Jun 22, 2023
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use...
Gastroenterology & Urology
190d
Cleared
Sep 26, 2022
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video...
Gastroenterology & Urology
28d
Cleared
Mar 29, 2019
Pusen Eview Medical Video Endoscope Image Processor
Gastroenterology & Urology
16d
Cleared
Aug 31, 2017
Medical Video Endoscope System
Gastroenterology & Urology
51d
Cleared
May 05, 2017
Medical Video Endoscope System
Gastroenterology & Urology
24d