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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 / March 2026 / K260003

510(k) cleared

KARL STORZ Mediastinoscopes and Instruments

Karl Storz SE & CO. KG · Mar 2, 2026 · K260003

FDA cleared the KARL STORZ Mediastinoscopes and Instruments from Karl Storz SE & CO. KG on Mar 2, 2026 under K260003, a traditional 510(k). The device falls under product code EWY, Mediastinoscope, Surgical, regulated at 21 CFR 874.4720 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jan 2, 2026. The decision came 59 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 K260003?

K260003 is the FDA 510(k) for KARL STORZ Mediastinoscopes and Instruments, submitted by Karl Storz SE & CO. KG. FDA's decision date was Mar 2, 2026, under product code EWY (Mediastinoscope, Surgical).

Who makes the KARL STORZ Mediastinoscopes and Instruments?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K260003.

How long did the K260003 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Mar 2, 2026, 59 days later.

← All decisions in March 2026