Cleared Traditional

ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K132433 · Acclarent, Inc. · Ear, Nose, Throat

Apr 2014

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K132433 is an FDA 510(k) clearance for the ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Acclarent, Inc. (Menlo Park, US). The FDA issued a Cleared decision on April 24, 2014, 262 days after receiving the submission on August 5, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K132433 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2013
Decision Date	April 24, 2014
Days to Decision	262 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).