510(k) K941228

ENDOLUMINAL ACCESS TUBE by Med Institute, Inc. — Product Code KNT

K941228 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "ENDOLUMINAL ACCESS TUBE". The FDA issued a decision of Substantially Equivalent (kit) on September 27, 1995. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Med Institute, Inc. has at least 10 other 510(k) clearances on record.