Cleared Traditional

CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX

K960915 · Clarus Medical Systems, Inc. · Neurology

Dec 1996

Decision

293d

Days

Class 2

Risk

About This 510(k) Submission

K960915 is an FDA 510(k) clearance for the CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX, 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 December 24, 1996, 293 days after receiving the submission on March 6, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K960915 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 1996
Decision Date	December 24, 1996
Days to Decision	293 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).