Cleared Special

VYBE RF Electrosurgical System

K230968 · ShenB Co., Ltd. · General & Plastic Surgery

Jul 2023

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K230968 is an FDA 510(k) clearance for the VYBE RF Electrosurgical System, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by ShenB Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 6, 2023, 92 days after receiving the submission on April 5, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K230968 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2023
Decision Date	July 06, 2023
Days to Decision	92 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).