FDA cleared the ENDOFLATOR+; Smart Smoke Evacuation from Karl Storz SE & CO. KG on Aug 19, 2026 under K260209, a traditional 510(k). The device falls under product code HIF, Insufflator, Laparoscopic, regulated at 21 CFR 884.1730 as a Class 2 device. The review panel was Obstetrics/Gynecology.
FDA logged the submission as received on Jan 23, 2026. The decision came 208 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: K254252 (UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)), K254303 (KARL STORZ SUPRALOOP), K261102 (UNIDRIVE Select System), K254299 (CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)).