510(k) K261102

UNIDRIVE Select System by Karl Storz SE & CO. KG — Product Code HIH

K261102 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "UNIDRIVE Select System". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.