
Pentax Precision Instrument Corp.
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PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) is an FDA 510(k)-cleared medical device (K953876) manufactured by Pentax Precision Instrument Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 1995. Regulation: 8.