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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 / K260773

510(k) cleared

Varios Combi Pro2

Nakanishi, Inc. · Mar 10, 2026 · K260773

FDA cleared the Varios Combi Pro2 from Nakanishi, Inc. on Mar 10, 2026 under K260773, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code ELC, Scaler, Ultrasonic, regulated at 21 CFR 872.4850 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 9, 2026. 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: K254163 (VarioSurg 4), 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 K260773?

K260773 is the FDA 510(k) for Varios Combi Pro2, submitted by Nakanishi, Inc.. FDA's decision date was Mar 10, 2026, under product code ELC (Scaler, Ultrasonic).

Who makes the Varios Combi Pro2?

Nakanishi, Inc., based in Kanuma, is the applicant of record for K260773.

How long did the K260773 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Mar 10, 2026, 1 days later.

← All decisions in March 2026

Sources