Cleared Traditional

InstaClear Lens Cleaner

K152531 · Gyrus Acmi, Inc. · Ear, Nose, Throat

Jan 2016

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K152531 is an FDA 510(k) clearance for the InstaClear Lens Cleaner, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on January 15, 2016, 134 days after receiving the submission on September 3, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K152531 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2015
Decision Date	January 15, 2016
Days to Decision	134 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).