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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 / K252388

510(k) cleared

Vanquish Water Vapor Ablation Device

Francis Medical, Inc. · Nov 26, 2025 · K252388

FDA cleared the Vanquish Water Vapor Ablation Device from Francis Medical, Inc. on Nov 26, 2025 under K252388, a traditional 510(k). The device falls under product code KNS, Unit, Electrosurgical, Endoscopic (With Or Without Accessories), regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 31, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Francis Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252388?

K252388 is the FDA 510(k) for Vanquish Water Vapor Ablation Device, submitted by Francis Medical, Inc.. FDA's decision date was Nov 26, 2025, under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)).

Who makes the Vanquish Water Vapor Ablation Device?

Francis Medical, Inc., based in Maple Grove, MN, is the applicant of record for K252388.

How long did the K252388 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Nov 26, 2025, 118 days later.

← All decisions in November 2025