Medical Device Manufacturer · US , Valparaiso , IN

Omnitech Systems, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1997

6

Total

6

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Jun 27, 2016

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode

Gastroenterology & Urology · 347d

Cleared May 27, 2005

OMNITECH FULGURATING ELECTRODE

Gastroenterology & Urology · 94d

Cleared Apr 22, 1997

RESECTOSCOPE CUTTING LOOP ELECTRODE

Gastroenterology & Urology · 172d

Cleared Mar 19, 1997

OMNITECH RESECTOSCOPE ROLLER ELECTRODE

Gastroenterology & Urology · 90d