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THE TAPE

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 / January 2026 / K254220

510(k) cleared

Reusable 3 Button Fingerswitch Wand

Soniquence, LLC · Jan 27, 2026 · K254220

FDA cleared the Reusable 3 Button Fingerswitch Wand from Soniquence, LLC on Jan 27, 2026 under K254220, a special 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 Dec 29, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Soniquence, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254220?

K254220 is the FDA 510(k) for Reusable 3 Button Fingerswitch Wand, submitted by Soniquence, LLC. FDA's decision date was Jan 27, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Reusable 3 Button Fingerswitch Wand?

Soniquence, LLC, based in Baldwin, NY, is the applicant of record for K254220.

How long did the K254220 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Jan 27, 2026, 29 days later.

← All decisions in January 2026