FDA.reportPublic FDA data

MONARCH™Platform, Urology

Primary DI
10810068811046
Brand
MONARCH™Platform, Urology
Company
Auris Health, Inc.
Model
MON-000007
Catalog number
MON-000007
Device description
Monarch Tower, Cart, and Fluidics Pump
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FGBUreteroscope And Accessories, Flexible/Rigid
LJHSystem, Irrigation, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2
LJHSystem, Irrigation, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213334000Monarch Platform, UrologyAuris Health, Inc.2022-04-29FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810068811043PackageGS11In Commercial Distribution
10810068811046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081006881104320810068811043
1081006881104610810068811046

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
10810068810940MONARCH™ Advanced Imaging Accessory KitMON-000709MON-0007092026-06-02
10810068810841MONARCH™ Navigation SensorsMON-000705MON-0007052026-05-27
10810068810858MONARCH™ ControllerMON-000706MON-0007062026-05-27
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
10810068810988Monarch Platform, Bronchoscopy 4.1MON-0000082025-03-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140757WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140764WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140771WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140788WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140795AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140801AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06979988682000Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25
06979988682017Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25