Cleared Traditional

Digital ClarusScope System, Digital NeuroPEN System

K223615 · Clarus Medical, LLC · Neurology

Nov 2023

Decision

351d

Days

Class 2

Risk

About This 510(k) Submission

K223615 is an FDA 510(k) clearance for the Digital ClarusScope System, Digital NeuroPEN System, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Clarus Medical, LLC (Plymouth, US). The FDA issued a Cleared decision on November 21, 2023, 351 days after receiving the submission on December 5, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K223615 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2022
Decision Date	November 21, 2023
Days to Decision	351 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).