FDA.reportPublic FDA data

Monarch Platform, Bronchoscopy 4.1

Primary DI
10810068810988
Brand
Monarch Platform, Bronchoscopy 4.1
Company
Auris Health, Inc.
Model
MON-000008
Device description
The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
Published
2025-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243219000MONARCH™ Platform (MON-000008)Auris Health, Inc.2025-01-23EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810068810985PackageGS11In Commercial Distribution
10810068810988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081006881098520810068810985
1081006881098810810068810988

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical telemanipulation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Regulatory Flags#

DUNS number
015823456
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810068810841MONARCH™ Navigation SensorsMON-000705MON-0007052026-05-27
10810068810858MONARCH™ ControllerMON-000706MON-0007062026-05-27
10810068811046MONARCH™Platform, UrologyMON-000007MON-0000072026-05-05
10810068811053Monarch® Ureteroscopy KitMUR-000011MUR-0000112026-05-05
10810068811077Monarch®Platform Drape KitMUR-000013MUR-0000132026-05-05
10810068811084MONARCH™ Kit Catheter & AccessoriesMUR-000014MUR-0000142026-05-05
10810068811114MONARCH™ Mini-PCNL Suction SetMUR-000017MUR-0000172026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitMUR-000012MUR-0000122026-05-04
10810068811091MONARCH™ Stone Retrieval BasketMUR-000015MUR-0000152026-05-04
10810068811107MONARCH™ Urology Irrigation CartridgeMUR-000016MUR-0000162026-05-04
10810068811121MONARCH™ Ureteroscope ValveMUR-000026MUR-0000262026-05-04
10810068811138MONARCH™ BronchoscopeMBR-000211-BMBR-000211-B2026-04-21
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedMON-000006-RFB2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedMON-000008-RFB2025-08-04
B634MON0007090Monarch Advanced Imaging Accessory KitMON-000709MON-0007092021-07-15
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)MON-0000062024-05-05
B634MON00000501R0Monarch Endoscopy Platform (P1) System, RefurbishedMON-000005-01R2020-03-25
B634MON000005010 Monarch Endoscopy Platform (P1) Tower UpgradeMON-000005-012020-07-13
B634MON00000501 Monarch Endoscopy Platform (P1) Tower UpgradeMON-000005-012020-03-25
B634MON0000060Monarch Bronchscope 2.0/Monarch Platform (P2)MON-0000062020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.EOQ2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12