WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / July 2026 / K261706

510(k) cleared

Endomat Select (UP220)

KARL STORZ SE & CO. KG · Jul 16, 2026 · K261706

FDA cleared the Endomat Select (UP220) from KARL STORZ SE & CO. KG on Jul 16, 2026 under K261706, a traditional 510(k). The device falls under product code HIG, Insufflator, Hysteroscopic, regulated at 21 CFR 884.1700 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on May 22, 2026. The decision came 55 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: K252800 (KARL STORZ Endoscopic Accessories for Urology), K252624 (KARL STORZ Laryngoscopes and Accessories), K254228 (KARL STORZ Trocars with Valve Seals), K260003 (KARL STORZ Mediastinoscopes and Instruments).

Questions & Answers

What did FDA clear under K261706?

K261706 is the FDA 510(k) for Endomat Select (UP220), submitted by KARL STORZ SE & CO. KG. FDA's decision date was Jul 16, 2026, under product code HIG (Insufflator, Hysteroscopic).

Who makes the Endomat Select (UP220)?

KARL STORZ SE & CO. KG, based in Tuttlingen, is the applicant of record for K261706.

How long did the K261706 review take?

FDA received the submission on May 22, 2026 and issued its decision on Jul 16, 2026, 55 days later.

← All decisions in July 2026