Cleared Traditional

K210379 - Broncho Videoscope System (FDA 510(k) Clearance)

K210379 · Scivita Medical Technology Co., Ltd. · Ear, Nose, Throat device

Jul 2021

Decision

169d

Days

Class 2

Risk

K210379 is an FDA 510(k) clearance for the Broncho Videoscope System. This device is classified as a Bronchoscope (flexible Or Rigid) (Class II - Special Controls, product code EOQ).

Submitted by Scivita Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 28, 2021, 169 days after receiving the submission on February 9, 2021.

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	K210379 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 2021
Decision Date	July 28, 2021
Days to Decision	169 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).