Cleared Traditional

K170285 - AED Sinuscope
(FDA 510(k) Clearance)

K170285 · National Advanced Endoscopy Devices, Inc. · Ear, Nose, Throat

Aug 2017

Decision

183d

Days

Class 2

Risk

K170285 is an FDA 510(k) clearance for the AED Sinuscope. This device is classified as a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB).

Submitted by National Advanced Endoscopy Devices, Inc. (Canoga Park, US). The FDA issued a Cleared decision on August 1, 2017, 183 days after receiving the submission on January 30, 2017.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4760. 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)..

Submission Details

510(k) Number	K170285 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2017
Decision Date	August 01, 2017
Days to Decision	183 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).