Cleared Traditional

Neuroblade System

K230125 · Clearmind Biomedical · Neurology

Oct 2023

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K230125 is an FDA 510(k) clearance for the Neuroblade System, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Clearmind Biomedical (Taipei, TW). The FDA issued a Cleared decision on October 13, 2023, 269 days after receiving the submission on January 17, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K230125 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2023
Decision Date	October 13, 2023
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWG — Endoscope, Neurological
Device Class	Class II — 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).