Cleared Traditional

CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)

K962255 · Clarus Medical Systems, Inc. · Ear, Nose, Throat

Sep 1996

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K962255 is an FDA 510(k) clearance for the CLARUS MURPHYPEN ENDOSCOPE(2127-XXX), a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 11, 1996, 91 days after receiving the submission on June 12, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K962255 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 1996
Decision Date	September 11, 1996
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
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).