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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 / July 2026 / K262152

510(k) cleared

VS-370CF, VS-370CT

VISION MEDICAL Co., Ltd. · Jul 24, 2026 · K262152

FDA cleared the VS-370CF, VS-370CT from VISION MEDICAL Co., Ltd. on Jul 24, 2026 under K262152, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code FCX, Insufflator, Automatic Carbon-Dioxide For Endoscope, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 25, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

VISION MEDICAL Co., Ltd. has one other decision in the tracker over the last 12 months: K253012 (AlignRT Plus (8.0)).

Questions & Answers

What did FDA clear under K262152?

K262152 is the FDA 510(k) for VS-370CF, VS-370CT, submitted by VISION MEDICAL Co., Ltd.. FDA's decision date was Jul 24, 2026, under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope).

Who makes the VS-370CF, VS-370CT?

VISION MEDICAL Co., Ltd., based in Incheon, is the applicant of record for K262152.

How long did the K262152 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Jul 24, 2026, 29 days later.

← All decisions in July 2026

Sources