Cleared Special

Soniquence Reusable Bipolar Cable

K211946 · Soniquence, LLC · General & Plastic Surgery

Jul 2021

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K211946 is an FDA 510(k) clearance for the Soniquence Reusable Bipolar Cable, 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 July 16, 2021, 23 days after receiving the submission on June 23, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K211946 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2021
Decision Date	July 16, 2021
Days to Decision	23 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).