510(k) K180026

Bowel Management Device, Bowel Management Irrigation Set by Applied Medical Technology, Inc. — Product Code KNT

K180026 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "Bowel Management Device, Bowel Management Irrigation Set". The FDA issued a decision of Substantially Equivalent (kit) on June 1, 2018. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.