510(k) K250388

ENDOFLATOR + by Karl Storz SE & CO. KG — Product Code HIF

K250388 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "ENDOFLATOR +". The FDA issued a decision of Substantially Equivalent on September 22, 2025. 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.