Cleared Traditional

CLARUS SPINEPEN MODEL 2126

K955598 · Clarus Medical Systems, Inc. · Neurology

Feb 1996

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K955598 is an FDA 510(k) clearance for the CLARUS SPINEPEN MODEL 2126, 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 February 6, 1996, 60 days after receiving the submission on December 8, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K955598 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 1995
Decision Date	February 06, 1996
Days to Decision	60 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).