Medical Device Manufacturer · US , Coralville , IA

Urosurge, Inc. - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 1998

Recent clearances: UROSURGE SPIRALFLO URETERAL STENT, UROSURGE SPIRASTENT PLUS URETERAL STENT, UROSURGE FILASTENT URETERAL STENT

4

Total

3

Cleared

1

Denied

FDA 510(k) Regulatory Record - Urosurge, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Not Cleared Feb 09, 2000

UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE

DEN000002 · NAM

Gastroenterology & Urology · 13d

Cleared Aug 18, 1999

UROSURGE SPIRALFLO URETERAL STENT

Gastroenterology & Urology · 30d

Cleared May 29, 1998

UROSURGE SPIRASTENT PLUS URETERAL STENT

Gastroenterology & Urology · 32d

Cleared May 29, 1998

UROSURGE FILASTENT URETERAL STENT

Gastroenterology & Urology · 32d