Cleared Traditional

K202180 - Broncoflex Agile (FDA 510(k) Clearance)

Also includes:

Product Reference: 20030001 , Broncoflex Vortex Product Reference: 10030001, Screeni Product Reference: 30030001

K202180 · Axess Vision Technology · Ear, Nose, Throat device

Oct 2020

Decision

79d

Days

Class 2

Risk

K202180 is an FDA 510(k) clearance for the Broncoflex Agile. This device is classified as a Bronchoscope (flexible Or Rigid) (Class II - Special Controls, product code EOQ).

Submitted by Axess Vision Technology (Joué-Lès-Tours, FR). The FDA issued a Cleared decision on October 22, 2020, 79 days after receiving the submission on August 4, 2020.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. 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)..

Submission Details

510(k) Number	K202180 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 04, 2020
Decision Date	October 22, 2020
Days to Decision	79 days
Submission Type	Traditional
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).