Cleared Traditional

K243429 - HJY VisualNext 3D Endoscopic Vision System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243429 · Hjy Smart Medical Device Co., Ltd. · Neurology device
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May 2025
Decision
197d
Days
Class 2
Risk

K243429 is an FDA 510(k) clearance for the HJY VisualNext 3D Endoscopic Vision System. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Hjy Smart Medical Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on May 21, 2025 after a review of 197 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hjy Smart Medical Device Co., Ltd. devices

Submission Details

510(k) Number K243429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 148d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWG Endoscope, Neurological
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWG Endoscope, Neurological

All 90
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K243429.
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