ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA

ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA is an FDA 510(k)-cleared medical device (K964561) manufactured by Bioenterics Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 10, 1997. Regulation: 8.