
Access Surgical Intl., Inc.
Free shipping on orders over $99 · 30-day returns
FLEX-I-PORT is an FDA 510(k)-cleared medical device (K940587) manufactured by Access Surgical Intl., Inc.. 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 March 28, 1994. Regulation: 8.