Monarch Platform

FDA 510(k) K193534 · Auris Health, Inc.

Substantially Equivalent

510(k) numberK193534

Submission

Device name
Monarch Platform
Applicant
Auris Health, Inc.
Redwood, CA, US
Received
December 20, 2019
Decision date
April 15, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EOQ – Bronchoscope (Flexible Or Rigid)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4680
Specialty
Ear, Nose, Throat

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…

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510(k)DeviceApplicantDecision
K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional Flexicare Medical Limited.09/02/2026SE
K260382MONARCH™ Platform (MON-000008)EOQ · Traditional Auris Health, Inc.07/25/2026SE
K254037LungFlow Airway CatheterEOQ · Traditional Free Flow Medical, Inc.07/10/2026SE
K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional Fujifilm Corporation06/16/2026SE
K260565SmartClip Delivery Catheter (ADR-1715)EOQ · Traditional Elucent Medical05/14/2026SE
K252341Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional Olympus Medical Systems Corp.04/23/2026SE
K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)EOQ · Traditional MacroLux Medical Technology Co., Ltd.04/08/2026SE
K250863FUJIFILM Ultrasonic Endoscope EB-710USEOQ · Traditional Fujifilm Corporation12/12/2025SE
K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)EOQ · Special Karl Storz SE & CO. KG12/05/2025SE
K252045Ion Endoluminal System (IF1000)EOQ · Traditional Intuitive Surgical, Inc.09/23/2025SE

More from Intuitive Surgical, Inc.

510(k)DeviceDecision
K260382MONARCH™ Platform (MON-000008)EOQ · Traditional 07/25/2026SE
K243219MONARCH™ Platform (MON-000008)EOQ · Traditional 01/23/2025SE
K213334Monarch Platform, UrologyFGB · Traditional 04/29/2022SE
K211493Monarch PlatformEOQ · Special 07/09/2021SE

Questions and answers

When was Monarch Platform cleared by the FDA?

Monarch Platform (K193534) received a 510(k) decision of Substantially Equivalent on April 15, 2020, 117 days after the submission was received.

What is the product code of K193534?

The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.