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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 / March 2026 / K253198

510(k) cleared

NanoKnife Generator (H78720300351US0)

Angiodynamics · Mar 24, 2026 · K253198

FDA cleared the NanoKnife Generator (H78720300351US0) from Angiodynamics on Mar 24, 2026 under K253198, a traditional 510(k). The device falls under product code OAB, Low Energy Direct Current Thermal Ablation System, 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 Sep 26, 2025. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Angiodynamics has 2 other decisions in the tracker over the last 12 months: K252509 (AlphaVac Multipurpose Mechanical Aspiration System F1885), K253106 (AngioVac Cannula).

Questions & Answers

What did FDA clear under K253198?

K253198 is the FDA 510(k) for NanoKnife Generator (H78720300351US0), submitted by Angiodynamics. FDA's decision date was Mar 24, 2026, under product code OAB (Low Energy Direct Current Thermal Ablation System).

Who makes the NanoKnife Generator (H78720300351US0)?

Angiodynamics, based in Marlborough, MA, is the applicant of record for K253198.

How long did the K253198 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Mar 24, 2026, 179 days later.

← All decisions in March 2026

Sources