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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 / K250927

510(k) cleared

KARL STORZ Cholangiography Set

Karl Storz SE & CO. KG · Nov 22, 2025 · K250927

FDA cleared the KARL STORZ Cholangiography Set from Karl Storz SE & CO. KG on Nov 22, 2025 under K250927, 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 28, 2025. The decision came 239 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), K254228 (KARL STORZ Trocars with Valve Seals).

Questions & Answers

What did FDA clear under K250927?

K250927 is the FDA 510(k) for KARL STORZ Cholangiography Set, submitted by Karl Storz SE & CO. KG. FDA's decision date was Nov 22, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the KARL STORZ Cholangiography Set?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K250927.

How long did the K250927 review take?

FDA received the submission on Mar 28, 2025 and issued its decision on Nov 22, 2025, 239 days later.

← All decisions in November 2025