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FDA 510(k)

Monarch Endoscopy Platform (Monarch Platform)

K-Number: K173760 · 2018-03-22

ApplicantAuris Surgical Robotics, Inc.
Decision Date2018-03-22
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Monarch Endoscopy Platform (Monarch Platform) is the device name listed in this FDA 510(k) record. The listed applicant is Auris Surgical Robotics, Inc.. It received FDA 510(k) clearance on 2018-03-22 under 510(k) number K173760. 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 Endoscopy Platform (Monarch Platform)?

Monarch Endoscopy Platform (Monarch Platform) is a medical device that received FDA 510(k) clearance on 2018-03-22. The listed applicant is Auris Surgical Robotics, Inc.. The 510(k) number is K173760.

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

Monarch Endoscopy Platform (Monarch Platform) received FDA 510(k) clearance on 2018-03-22, under 510(k) number K173760.

Who is the listed applicant for Monarch Endoscopy Platform (Monarch Platform)?

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

What is the FDA product code for Monarch Endoscopy Platform (Monarch Platform)?

The FDA product code for Monarch Endoscopy Platform (Monarch Platform) is EOQ.

Related Clinical Trials

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.

NCT05231278Confocal Laser Endomicroscopy Nodule Localization by Robotic BronchoscopyCOMPLETED

Other records listing Auris Surgical Robotics, 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.

K152319Auris Robotic Endoscopy System (ARES)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.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.

Official Source

View on FDA Database →

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

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