MONARCH™ Platform (MON-000008)

FDA 510(k) K260382 · Auris Health, Inc.

Substantially Equivalent

510(k) numberK260382

Submission

Device name
MONARCH™ Platform (MON-000008)
Applicant
Auris Health, Inc.
Santa Clara, CA, US
Received
February 5, 2026
Decision date
July 25, 2026
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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More from Himaging Technology (Shanghai) Co., Ltd.

510(k)DeviceDecision
K243219MONARCH™ Platform (MON-000008)EOQ · Traditional 01/23/2025SE
K213334Monarch Platform, UrologyFGB · Traditional 04/29/2022SE
K211493Monarch PlatformEOQ · Special 07/09/2021SE
K193534Monarch PlatformEOQ · Traditional 04/15/2020SE

Questions and answers

When was MONARCH™ Platform (MON-000008) cleared by the FDA?

MONARCH™ Platform (MON-000008) (K260382) received a 510(k) decision of Substantially Equivalent on July 25, 2026, 170 days after the submission was received.

What is the product code of K260382?

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