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510(k) K223615

Digital ClarusScope System, Digital NeuroPEN System by Clarus Medical, LLC — Product Code GWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
December 5, 2022
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 Clarus Medical, LLC

  • K240535 — Digital ClarusScope System; Digital NeuroPEN System (April 25, 2024)
  • K200925 — Clarus Peel-Away Introducer Sheath (March 18, 2021)
  • K082038 — CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V (April 28, 2009)
  • K040919 — NUCLEOTOME PROBE SET, MODEL 21200 (June 1, 2004)
  • K040424 — LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, (May 11, 2004)
  • K022610 — CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, (November 5, 2002)
  • K021848 — CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, (September 3, 2002)
  • K011454 — SPINE SCOPE, MODEL 2180 (December 13, 2001)

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)
  • 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)