510(k) K173955

Mic-Key* SF Over-the-Wire Stoma Measuring Device by Halyard Health, Inc. — Product Code KNT

K173955 is an FDA 510(k) premarket notification submitted by Halyard Health, Inc. for the device "Mic-Key* SF Over-the-Wire Stoma Measuring Device". The FDA issued a decision of Substantially Equivalent (kit) on January 26, 2018. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Halyard Health, Inc. has at least 10 other 510(k) clearances on record.