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FDA 510(k)

Reusable 3 Button Fingerswitch Wand

K-Number: K254220 · 2026-01-27

ApplicantSoniquence, LLC
Decision Date2026-01-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reusable 3 Button Fingerswitch Wand is the device name listed in this FDA 510(k) record. The listed applicant is Soniquence, LLC. It received FDA 510(k) clearance on 2026-01-27 under 510(k) 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. The listed applicant is Soniquence, LLC. The 510(k) number is K254220.

When did Reusable 3 Button Fingerswitch Wand receive FDA 510(k) clearance?

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

Who is the listed applicant for Reusable 3 Button Fingerswitch Wand?

The FDA 510(k) record lists Soniquence, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Soniquence, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212222Soniquence Reusable 3 Button Fingerswitch WandK220071Soniquence Reusable Neutral PlateK211946Soniquence Reusable Bipolar CableK190336Soniquence Bipolar ElectrodesK183611Soniquence RF Generator and Soniquence Electrodes

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

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