Cleared Traditional

Broncho Videoscope System

K231521 · Scivita Medical Technology Co., Ltd. · Ear, Nose, Throat

Nov 2023

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K231521 is an FDA 510(k) clearance for the Broncho Videoscope System, 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 November 14, 2023, 172 days after receiving the submission on May 26, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K231521 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 2023
Decision Date	November 14, 2023
Days to Decision	172 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).