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510(k) K243429

HJY VisualNext 3D Endoscopic Vision System by Hjy Smart Medical Device Co., Ltd. — Product Code GWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2025
Date Received
November 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Neurological
Device Class
Class II
Regulation Number
882.1480
Review Panel
NE
Submission Type

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).

Other clearances by Hjy Smart Medical Device Co., Ltd.

  • K222735 — HJY VisualNext Endoscopic Vision System (July 28, 2023)

Other clearances for product code GWG

  • K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (April 9, 2025)
  • K233391 — cCeLL - In vivo (August 21, 2024)
  • K223615 — Digital ClarusScope System, Digital NeuroPEN System (November 21, 2023)
  • K232618 — Aurora Surgiscope System (October 27, 2023)
  • K230125 — Neuroblade System (October 13, 2023)
  • K232159 — QEVO System (September 21, 2023)
  • K222735 — HJY VisualNext Endoscopic Vision System (July 28, 2023)
  • K211202 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Preci (August 6, 2021)
  • K210251 — ClearPath Disposable Introducer (April 2, 2021)
  • K200925 — Clarus Peel-Away Introducer Sheath (March 18, 2021)