Medical Device Manufacturer · CA , Mississauga, Ontario

Mui Scientific - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1983

Recent clearances: Rapid Barostat Bag (RBB) Pump and Catheter, PRESSURIZED INFUSION PUMP, SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mui Scientific Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Mar 14, 2017

Rapid Barostat Bag (RBB) Pump and Catheter

Gastroenterology & Urology · 405d

Cleared Nov 01, 2012

PRESSURIZED INFUSION PUMP

Gastroenterology & Urology · 93d

Cleared Jun 21, 2012

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

Gastroenterology & Urology · 120d

Cleared Feb 15, 1983

MOTILITY CATHETERS

Gastroenterology & Urology · 69d