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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 / June 2026 / K253302

510(k) cleared

Hemospray Endoscopic Hemostat (HEMO-[X])

Wilson-Cook Medical, Inc. · Jun 2, 2026 · K253302

FDA cleared the Hemospray Endoscopic Hemostat (HEMO-[X]) from Wilson-Cook Medical, Inc. on Jun 2, 2026 under K253302, a traditional 510(k). The device falls under product code QAU, Hemostatic Device For Endoscopic Gastrointestinal Use, regulated at 21 CFR 878.4456 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 29, 2025. The decision came 246 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wilson-Cook Medical, Inc. has one other decision in the tracker over the last 12 months: K251104 (SureTome SW Sphincterotome with DomeTip).

Questions & Answers

What did FDA clear under K253302?

K253302 is the FDA 510(k) for Hemospray Endoscopic Hemostat (HEMO-[X]), submitted by Wilson-Cook Medical, Inc.. FDA's decision date was Jun 2, 2026, under product code QAU (Hemostatic Device For Endoscopic Gastrointestinal Use).

Who makes the Hemospray Endoscopic Hemostat (HEMO-[X])?

Wilson-Cook Medical, Inc., based in Winston-Salem, NC, is the applicant of record for K253302.

How long did the K253302 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 2, 2026, 246 days later.

← All decisions in June 2026

Sources