Medical Device Manufacturer · US , Montvale , NJ

Pentax Medical Company - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2004

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pentax Medical Company Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Apr 10, 2014

PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)

Gastroenterology & Urology · 289d

Cleared Apr 09, 2014

PENTAX VIDEO COLONOSCOPES (EC FAMILY)

Gastroenterology & Urology · 292d

Cleared Dec 28, 2009

PENTEX EC-3890LI

Gastroenterology & Urology · 90d

Cleared Dec 02, 2009

PENTAX ED-3490TK, VIDEO DUODENOSCOPE

Gastroenterology & Urology · 90d