Cleared Traditional

FINESS ENDOSCOPE

K102366 · Entellus Medical, Inc. · Ear, Nose, Throat

Feb 2011

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K102366 is an FDA 510(k) clearance for the FINESS ENDOSCOPE, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 15, 2011, 179 days after receiving the submission on August 20, 2010. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K102366 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2010
Decision Date	February 15, 2011
Days to Decision	179 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).