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510(k) K254220

Reusable 3 Button Fingerswitch Wand by Soniquence, LLC — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2026
Date Received
December 29, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Soniquence, LLC

  • K212222 — Soniquence Reusable 3 Button Fingerswitch Wand (September 2, 2022)
  • K220071 — Soniquence Reusable Neutral Plate (February 3, 2022)
  • K211946 — Soniquence Reusable Bipolar Cable (July 16, 2021)
  • K190336 — Soniquence Bipolar Electrodes (June 20, 2019)
  • K183611 — Soniquence RF Generator and Soniquence Electrodes (May 22, 2019)

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