Pentax of America, Inc.

Pentax of America, Inc. — FDA 510(k) Submissions

Pentax of America, Inc. has submitted 44 FDA 510(k) premarket notifications since 2012, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bronchoscope (flexible Or Rigid), Endoscopic Ultrasound System, Gastroenterology-urology, Endoscope, Accessories, Image Post-processing For Color Enhancement, Gastroscope And Accessories, Flexible/rigid, Duodenoscope And Accessories, Flexible/rigid . Use the specialty filter in the sidebar to narrow results.