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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 / September 2025 / K251104

510(k) cleared

SureTome SW Sphincterotome with DomeTip

Wilson-Cook Medical · Sep 29, 2025 · K251104

FDA cleared the SureTome SW Sphincterotome with DomeTip from Wilson-Cook Medical on Sep 29, 2025 under K251104, 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 Apr 11, 2025. The decision came 171 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wilson-Cook Medical has one other decision in the tracker over the last 12 months: K253302 (Hemospray Endoscopic Hemostat (HEMO-[X])).

Questions & Answers

What did FDA clear under K251104?

K251104 is the FDA 510(k) for SureTome SW Sphincterotome with DomeTip, submitted by Wilson-Cook Medical. FDA's decision date was Sep 29, 2025, under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)).

Who makes the SureTome SW Sphincterotome with DomeTip?

Wilson-Cook Medical, based in Winston-Salem, NC, is the applicant of record for K251104.

How long did the K251104 review take?

FDA received the submission on Apr 11, 2025 and issued its decision on Sep 29, 2025, 171 days later.

← All decisions in September 2025

Sources