Cleared Traditional

LoopView? Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub? Video Processor (S13)

K233779 · MacroLux Medical Technology Co., Ltd. · Ear, Nose, Throat

Apr 2024

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K233779 is an FDA 510(k) clearance for the LoopView? Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub? Video Processor (S13), a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by MacroLux Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 5, 2024, 130 days after receiving the submission on November 27, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K233779 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2023
Decision Date	April 05, 2024
Days to Decision	130 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).