Medical Device Manufacturer · US , Mission Viejo , CA

Onset Medical Corporation - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2005

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Onset Medical Corporation Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared May 02, 2006

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

Gastroenterology & Urology · 20d

Cleared Feb 10, 2005

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

Gastroenterology & Urology · 78d