510(k) K180735

Endomat Select by Karl Storz SE & CO. KG — Product Code HIG

K180735 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "Endomat Select". The FDA issued a decision of Substantially Equivalent on October 31, 2018. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.