FDA cleared the UNIDRIVE Select System from Karl Storz SE & CO. KG on Sep 1, 2026 under K260884, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.
FDA logged the submission as received on Mar 17, 2026. The decision came 168 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: K254103 (HOPKINS Telescopes for Arthroscopy), K260209 (ENDOFLATOR+; Smart Smoke Evacuation), K261706 (Endomat Select (UP220)), K252800 (KARL STORZ Endoscopic Accessories for Urology).