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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 / December 2025 / K254163

510(k) cleared

VarioSurg 4

Nakanishi, Inc. · Dec 23, 2025 · K254163

FDA cleared the VarioSurg 4 from Nakanishi, Inc. on Dec 23, 2025 under K254163, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code DZI, Drill, Bone, Powered, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 22, 2025. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Nakanishi, Inc. has 3 other decisions in the tracker over the last 12 months: K260773 (Varios Combi Pro2), K251689 (VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)), K252662 (UniBur).

Questions & Answers

What did FDA clear under K254163?

K254163 is the FDA 510(k) for VarioSurg 4, submitted by Nakanishi, Inc.. FDA's decision date was Dec 23, 2025, under product code DZI (Drill, Bone, Powered).

Who makes the VarioSurg 4?

Nakanishi, Inc., based in Kanuma, is the applicant of record for K254163.

How long did the K254163 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Dec 23, 2025, 1 days later.

← All decisions in December 2025

Sources