ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 is an FDA 510(k)-cleared medical device (K093718) manufactured by Zutron Medical, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 21, 2010. Regulation: 8.