Cleared Special

Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set

K223782 · Ambu A/S · Ear, Nose, Throat

Jan 2023

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K223782 is an FDA 510(k) clearance for the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set, 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 January 12, 2023, 27 days after receiving the submission on December 16, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K223782 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2022
Decision Date	January 12, 2023
Days to Decision	27 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).