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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 / April 2026 / K253777

510(k) cleared

Ascblue (8010)

Ascblue Corporation · Apr 10, 2026 · K253777

FDA cleared the Ascblue (8010) from Ascblue Corporation on Apr 10, 2026 under K253777, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 26, 2025. The decision came 135 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 Ascblue Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253777?

K253777 is the FDA 510(k) for Ascblue (8010), submitted by Ascblue Corporation. FDA's decision date was Apr 10, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Ascblue (8010)?

Ascblue Corporation, based in Brea, CA, is the applicant of record for K253777.

How long did the K253777 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Apr 10, 2026, 135 days later.

← All decisions in April 2026