Cleared Traditional

Dillard Airway Dilatation System

K153484 · Intuit Medical Products, LLC · Ear, Nose, Throat

Jul 2016

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K153484 is an FDA 510(k) clearance for the Dillard Airway Dilatation System, a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Intuit Medical Products, LLC (Sugar Hill, US). The FDA issued a Cleared decision on July 27, 2016, 237 days after receiving the submission on December 3, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K153484 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2015
Decision Date	July 27, 2016
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
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).