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Reusable 3 Button Fingerswitch Wand

Soniquence, LLC

Country / Region:United States (US)Submission type:Special

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

United States (US)

Product code

GEI
21 CFR 878.4400

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K254220
Device name
Reusable 3 Button Fingerswitch Wand
Country / Region
United States(US)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2025-12-29
Decision date
2026-01-27
Submission type
Special
Technology type
RF Generator(AI inferred)
Clinical applications
Surgery
Primary application
Surgery
Classification source
AI classified

Indications for Use

The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures.

Intended Use

The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures.

Device Description

The Soniquence 3-Button Fingerswitch Wand is an accessory intended for use with the Soniquence SmoothWave RF Generator. The device connects to a high-frequency generator via a male connector, and the distal female connector interfaces with a compatible Soniquence monopolar electrode. The device is supplied non-sterile and is intended for use with Soniquence monopolar electrodes. The 3-Button Fingerswitch Wand provides user access to three monopolar waveforms without the need for generator front-panel manipulation. The handpiece enables activation of CUT, BLEND, and HEMO modes via integrated finger-actuated switches. When a button is depressed, the corresponding mode is activated regardless of the generator display settings. Visual indicators illuminate to confirm activation of the selected mode. a) The CUT button will activate CUT mode. When depressed, the yellow indicator (CUT) illuminates. b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates. c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

Summary parsed at:2026-06-19 06:03:24 UTC

Predicate devices

2

K254220 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K254220 as a predicate