FDA 510(k)

Reusable 3 Button Fingerswitch Wand

K-Number: K254220 · 2026-01-27

Decision Date2026-01-27

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Reusable 3 Button Fingerswitch Wand is a medical device manufactured by Soniquence, LLC. It received FDA 510(k) clearance on 2026-01-27 under approval number K254220. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reusable 3 Button Fingerswitch Wand?

Reusable 3 Button Fingerswitch Wand is a medical device that received FDA 510(k) clearance on 2026-01-27. It is manufactured by Soniquence, LLC. The 510(k) number is K254220.

When was Reusable 3 Button Fingerswitch Wand approved by the FDA?

Reusable 3 Button Fingerswitch Wand received FDA 510(k) clearance on 2026-01-27, under approval number K254220.

What company makes Reusable 3 Button Fingerswitch Wand?

Reusable 3 Button Fingerswitch Wand is manufactured by Soniquence, LLC.

What is the FDA product code for Reusable 3 Button Fingerswitch Wand?

The FDA product code for Reusable 3 Button Fingerswitch Wand is GEI.

Other Devices by Soniquence, LLC

K190336Soniquence Bipolar Electrodes K183611Soniquence RF Generator and Soniquence Electrodes K211946Soniquence Reusable Bipolar Cable K212222Soniquence Reusable 3 Button Fingerswitch Wand K220071Soniquence Reusable Neutral Plate

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.