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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 / November 2025 / K253411

510(k) cleared

Miniature Telescope for Urology (27033AA)

Karl Storz SE & CO. KG · Nov 18, 2025 · K253411

FDA cleared the Miniature Telescope for Urology (27033AA) from Karl Storz SE & CO. KG on Nov 18, 2025 under K253411, a traditional 510(k). The device falls under product code FGB, Ureteroscope And Accessories, Flexible/Rigid, 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 30, 2025. The decision came 49 days later, inside the 90 FDA-day goal for a 510(k).

Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: K261706 (Endomat Select (UP220)), K252800 (KARL STORZ Endoscopic Accessories for Urology), K252624 (KARL STORZ Laryngoscopes and Accessories), K254228 (KARL STORZ Trocars with Valve Seals).

Questions & Answers

What did FDA clear under K253411?

K253411 is the FDA 510(k) for Miniature Telescope for Urology (27033AA), submitted by Karl Storz SE & CO. KG. FDA's decision date was Nov 18, 2025, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the Miniature Telescope for Urology (27033AA)?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K253411.

How long did the K253411 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Nov 18, 2025, 49 days later.

← All decisions in November 2025