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
FDA 510(k) Regulatory Record - Zhuhai Pusen Medical Technology Co., Ltd. Gastroenterology & Urology ✕
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