Cleared Traditional

INSTRUMENT SCOPE

K953685 · Clarus Medical Systems, Inc. · Neurology

Oct 1995

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K953685 is an FDA 510(k) clearance for the INSTRUMENT SCOPE, 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 October 12, 1995, 66 days after receiving the submission on August 7, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K953685 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 1995
Decision Date	October 12, 1995
Days to Decision	66 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).