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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 / May 2026 / K254228

510(k) cleared

KARL STORZ Trocars with Valve Seals

Karl Storz SE & CO. KG · May 11, 2026 · K254228

FDA cleared the KARL STORZ Trocars with Valve Seals from Karl Storz SE & CO. KG on May 11, 2026 under K254228, 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 Dec 26, 2025. The decision came 136 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)), K252800 (KARL STORZ Endoscopic Accessories for Urology), K252624 (KARL STORZ Laryngoscopes and Accessories), K260003 (KARL STORZ Mediastinoscopes and Instruments).

Questions & Answers

What did FDA clear under K254228?

K254228 is the FDA 510(k) for KARL STORZ Trocars with Valve Seals, submitted by Karl Storz SE & CO. KG. FDA's decision date was May 11, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the KARL STORZ Trocars with Valve Seals?

Karl Storz SE & CO. KG, based in Tuttlingen, DE, is the applicant of record for K254228.

How long did the K254228 review take?

FDA received the submission on Dec 26, 2025 and issued its decision on May 11, 2026, 136 days later.

← All decisions in May 2026