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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 / September 2025 / K252662

510(k) cleared

UniBur

Nakanishi, Inc. · Sep 19, 2025 · K252662

FDA cleared the UniBur from Nakanishi, Inc. on Sep 19, 2025 under K252662, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered), regulated at 21 CFR 882.4310 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 22, 2025. The decision came 28 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), K254163 (VarioSurg 4), K251689 (VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)).

Questions & Answers

What did FDA clear under K252662?

K252662 is the FDA 510(k) for UniBur, submitted by Nakanishi, Inc.. FDA's decision date was Sep 19, 2025, under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)).

Who makes the UniBur?

Nakanishi, Inc., based in Kanuma, is the applicant of record for K252662.

How long did the K252662 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Sep 19, 2025, 28 days later.

← All decisions in September 2025

Sources