Cleared Traditional

ULTRA Telescopes

K153009 · Olympus Winter & Ibe GmbH · Ear, Nose, Throat

Apr 2016

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K153009 is an FDA 510(k) clearance for the ULTRA Telescopes, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on April 5, 2016, 174 days after receiving the submission on October 14, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K153009 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 2015
Decision Date	April 05, 2016
Days to Decision	174 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).