Cleared Traditional

NEURO CHANNEL ENDOSCOPE MODEL 2232

K945633 · Clarus Medical Systems, Inc. · Neurology

Sep 1995

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K945633 is an FDA 510(k) clearance for the NEURO CHANNEL ENDOSCOPE MODEL 2232, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 19, 1995, 307 days after receiving the submission on November 16, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K945633 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 1994
Decision Date	September 19, 1995
Days to Decision	307 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).