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FDA 510(k)

Monarch Platform, Urology

K-Number: K213334 · 2022-04-29

ApplicantAuris Health, Inc.
Decision Date2022-04-29
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Monarch Platform, Urology 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 2022-04-29 under 510(k) number K213334. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monarch Platform, Urology?

Monarch Platform, Urology is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Auris Health, Inc.. The 510(k) number is K213334.

When did Monarch Platform, Urology receive FDA 510(k) clearance?

Monarch Platform, Urology received FDA 510(k) clearance on 2022-04-29, under 510(k) number K213334.

Who is the listed applicant for Monarch Platform, Urology?

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, Urology?

The FDA product code for Monarch Platform, Urology is FGB.

Related Clinical Trials

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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.

K260382MONARCH™ Platform (MON-000008)K243219MONARCH™ Platform (MON-000008)K211493Monarch PlatformK193534Monarch Platform

Related Devices (Code: FGB)

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.

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument Co., Ltd.

Official Source

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