LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE is an FDA 510(k)-cleared medical device (K912839) manufactured by Baxter Healthcare Corp. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 24, 1991. Regulation: 8.