Promepla Sam - FDA 510(k) Cleared Devices
Recent clearances: Bi-Flex Evo, RocaJJ Soft Stents
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Promepla Sam Gastroenterology & Urology ✕
5 devices
Cleared
Sep 07, 2018
Bi-Flex Evo
Gastroenterology & Urology
30d
Cleared
Mar 12, 2018
RocaJJ Soft Stents
Gastroenterology & Urology
96d
Cleared
Feb 09, 2016
ENDOFLOW II - Irrigation, Warming and Suction System
Gastroenterology & Urology
181d
Cleared
Jun 17, 2014
BI-FLEX URETERAL ACCESS SHEATH
Gastroenterology & Urology
116d
Cleared
May 14, 2012
ROCAMED ROCAUS PLATINUM
Gastroenterology & Urology
116d