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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 / K253656

510(k) cleared

OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System

Medtronic Sofamor Danek USA, Inc. · Jun 5, 2026 · K253656

FDA cleared the OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System from Medtronic Sofamor Danek USA, Inc. on Jun 5, 2026 under K253656, 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 20, 2025. The decision came 197 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Sofamor Danek USA, Inc. has 7 other decisions in the tracker over the last 12 months: K253011 (Catalyft PL Expandable Interbody System), K261020 (Symmetrix L Spinal System), K260216 (CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System), K254165 (Infinity OCT System).

Questions & Answers

What did FDA clear under K253656?

K253656 is the FDA 510(k) for OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System, submitted by Medtronic Sofamor Danek USA, Inc.. FDA's decision date was Jun 5, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System?

Medtronic Sofamor Danek USA, Inc., based in Memphis, TN, is the applicant of record for K253656.

How long did the K253656 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Jun 5, 2026, 197 days later.

← All decisions in June 2026