Cleared Special

Ambu? aScope? 5 Broncho 4.2/2.2 Sampler Set

K232582 · Ambu A/S · Ear, Nose, Throat

Sep 2023

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K232582 is an FDA 510(k) clearance for the Ambu? aScope? 5 Broncho 4.2/2.2 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 September 20, 2023, 26 days after receiving the submission on August 25, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K232582 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2023
Decision Date	September 20, 2023
Days to Decision	26 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).