510(k) K131434

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM by Visionsense, Ltd. — Product Code GWG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 16, 2013
Date Received: May 17, 2013
Clearance Type: Special
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 Visionsense, Ltd.

K223020 — VS3-Iridium System (VS3-IR) (October 28, 2022)
K210265 — VS3 Iridium Sytem (November 22, 2021)
K171208 — Trans-anal Introducer (February 5, 2018)
K153548 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (February 22, 2016)
K152204 — VS3-IR system (October 28, 2015)
K150018 — VS3-IR-MMS System (June 17, 2015)
K141002 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (June 26, 2014)
K123467 — VS3 (April 17, 2013)
K082355 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (December 15, 2008)
K082667 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) (October 30, 2008)

Other clearances for product code GWG

K243429 — HJY VisualNext 3D Endoscopic Vision System (May 21, 2025)
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)