510(k) K260209

ENDOFLATOR+; Smart Smoke Evacuation by Karl Storz SE & CO. KG — Product Code HIF

K260209 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "ENDOFLATOR+; Smart Smoke Evacuation". The FDA issued a decision of Substantially Equivalent on August 19, 2026. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.