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FDA 510(k)

MONARCH™ Platform (MON-000008)

K-Number: K260382 · 2026-07-25

ApplicantAuris Health, Inc.
Decision Date2026-07-25
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MONARCH™ Platform (MON-000008) is the device name listed in this FDA 510(k) record. The listed applicant is Auris Health, Inc.. It received FDA 510(k) clearance on 2026-07-25 under 510(k) number K260382. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH™ Platform (MON-000008)?

MONARCH™ Platform (MON-000008) is a medical device that received FDA 510(k) clearance on 2026-07-25. The listed applicant is Auris Health, Inc.. The 510(k) number is K260382.

When did MONARCH™ Platform (MON-000008) receive FDA 510(k) clearance?

MONARCH™ Platform (MON-000008) received FDA 510(k) clearance on 2026-07-25, under 510(k) number K260382.

Who is the listed applicant for MONARCH™ Platform (MON-000008)?

The FDA 510(k) record lists Auris Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONARCH™ Platform (MON-000008)?

The FDA product code for MONARCH™ Platform (MON-000008) is EOQ.

Other records listing Auris Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243219MONARCH™ Platform (MON-000008)K213334Monarch Platform, UrologyK211493Monarch PlatformK193534Monarch Platform

Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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