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510(k) K230125

Neuroblade System by Clearmind Biomedical — Product Code GWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2023
Date Received
January 17, 2023
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 Clearmind Biomedical

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  • K201308 — Axonpen, Axonmonitor, Axonbox, Tablet (November 27, 2020)

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  • K233391 — cCeLL - In vivo (August 21, 2024)
  • K223615 — Digital ClarusScope System, Digital NeuroPEN System (November 21, 2023)
  • K232618 — Aurora Surgiscope System (October 27, 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)