Cleared Traditional

K222735 - HJY VisualNext Endoscopic Vision System

K222735 is an FDA 510(k) clearance for HJY VisualNext Endoscopic Vision System, manufactured by Hjy Smart Medical Device Co., Ltd.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K222735 · Hjy Smart Medical Device Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 2023
Decision
322d
Days
Class 2
Risk

K222735 is an FDA 510(k) clearance for the HJY VisualNext Endoscopic Vision System. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Hjy Smart Medical Device Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on July 28, 2023 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K222735

510(k) Number K222735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2022
Decision Date July 28, 2023
Days to Decision 322 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
174d slower than avg
Panel avg: 148d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWG Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K222735.
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