Cleared Traditional

HJY VisualNext 3D Endoscopic Vision System

K243429 · Hjy Smart Medical Device Co., Ltd. · Neurology

May 2025

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K243429 is an FDA 510(k) clearance for the HJY VisualNext 3D Endoscopic Vision System, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Hjy Smart Medical Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on May 21, 2025, 197 days after receiving the submission on November 5, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K243429 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2024
Decision Date	May 21, 2025
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWG — Endoscope, Neurological
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1480
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).