Cleared Special

Soniquence Reusable 3 Button Fingerswitch Wand

K212222 · Soniquence, LLC · General & Plastic Surgery

Sep 2022

Decision

413d

Days

Class 2

Risk

About This 510(k) Submission

K212222 is an FDA 510(k) clearance for the Soniquence Reusable 3 Button Fingerswitch Wand, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Soniquence, LLC (Baldwin, US). The FDA issued a Cleared decision on September 2, 2022, 413 days after receiving the submission on July 16, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K212222 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2021
Decision Date	September 02, 2022
Days to Decision	413 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	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).