FDA cleared the KARL STORZ SUPRALOOP from Karl Storz SE & CO. KG on Sep 24, 2026 under K254303, a traditional 510(k). The device falls under product code KNF, Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), regulated at 21 CFR 884.4160 as a Class 2 device. The review panel was Obstetrics/Gynecology.
FDA logged the submission as received on Dec 31, 2025. The decision came 267 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)), K261102 (UNIDRIVE Select System), K254299 (CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)), K260884 (UNIDRIVE Select System).