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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K252800

510(k) cleared

KARL STORZ Endoscopic Accessories for Urology

Karl Storz SE & CO. KG · Jun 3, 2026 · K252800

FDA cleared the KARL STORZ Endoscopic Accessories for Urology from Karl Storz SE & CO. KG on Jun 3, 2026 under K252800, a traditional 510(k). The device falls under product code OCZ, Endoscopic Grasping/Cutting Instrument, Non-Powered, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 3, 2025. The decision came 273 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: K261706 (Endomat Select (UP220)), K252624 (KARL STORZ Laryngoscopes and Accessories), K254228 (KARL STORZ Trocars with Valve Seals), K260003 (KARL STORZ Mediastinoscopes and Instruments).

Questions & Answers

What did FDA clear under K252800?

K252800 is the FDA 510(k) for KARL STORZ Endoscopic Accessories for Urology, submitted by Karl Storz SE & CO. KG. FDA's decision date was Jun 3, 2026, under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered).

Who makes the KARL STORZ Endoscopic Accessories for Urology?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K252800.

How long did the K252800 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on Jun 3, 2026, 273 days later.

← All decisions in June 2026