510(k) K180752

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole by Corinth Medtech, Inc. — Product Code HIH

K180752 is an FDA 510(k) premarket notification submitted by Corinth Medtech, Inc. for the device "Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole". The FDA issued a decision of Substantially Equivalent on July 25, 2018. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Corinth Medtech, Inc. has at least 6 other 510(k) clearances on record.