Cleared Traditional

ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE

K082569 · Entellus Medical, Inc. · Ear, Nose, Throat

Sep 2008

Decision

13d

Days

Class 2

Risk

About This 510(k) Submission

K082569 is an FDA 510(k) clearance for the ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 18, 2008, 13 days after receiving the submission on September 5, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K082569 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2008
Decision Date	September 18, 2008
Days to Decision	13 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).