Cleared Special

Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor

K161656 · Ambu A/S · Ear, Nose, Throat

Sep 2016

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K161656 is an FDA 510(k) clearance for the Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on September 1, 2016, 77 days after receiving the submission on June 16, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K161656 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2016
Decision Date	September 01, 2016
Days to Decision	77 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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).