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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 / K253504

510(k) cleared

Volnewmer

Classys, Inc. · Jul 13, 2026 · K253504

FDA cleared the Volnewmer from Classys, Inc. on Jul 13, 2026 under K253504, 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 Oct 31, 2025. The decision came 255 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Classys, Inc. has one other decision in the tracker over the last 12 months: K253123 (CuRAS hybrid).

Questions & Answers

What did FDA clear under K253504?

K253504 is the FDA 510(k) for Volnewmer, submitted by Classys, Inc.. FDA's decision date was Jul 13, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Volnewmer?

Classys, Inc., based in Seoul, is the applicant of record for K253504.

How long did the K253504 review take?

FDA received the submission on Oct 31, 2025 and issued its decision on Jul 13, 2026, 255 days later.

← All decisions in July 2026

Sources