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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 / February 2026 / K253972

510(k) cleared

IMAGE1 (TC400US); X-to-4U Adapter (TC040)

Karl Storz SE & CO. KG · Feb 12, 2026 · K253972

FDA cleared the IMAGE1 (TC400US); X-to-4U Adapter (TC040) from Karl Storz SE & CO. KG on Feb 12, 2026 under K253972, a traditional 510(k). The device falls under product code OWN, Confocal Optical Imaging, 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 11, 2025. The decision came 63 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 K253972?

K253972 is the FDA 510(k) for IMAGE1 (TC400US); X-to-4U Adapter (TC040), submitted by Karl Storz SE & CO. KG. FDA's decision date was Feb 12, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K253972.

How long did the K253972 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Feb 12, 2026, 63 days later.

← All decisions in February 2026