MONARCH? Platform (MON-000008)
Auris Health, Inc.
Auris Health, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023460764 | 3023460764 | Auris Health, Inc. | 1 | N | 2026-01-01 | 170 Baytech Drive San Jose CA US 95134 |
| 3008975424 | 3008975424 | AURIS HEALTH, INC. | 1 | N | 2020-04-25 | 2383 Bering Dr San Jose CA US 95131 |
| 3014447948 | 3014447948 | AURIS HEALTH, INC. | 1 | N | 2020-04-25 | 150 Shoreline Drive Redwood City CA US 94065 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 307997 | 1087565559 | K260382 | MONARCH™ Platform (MON-000008) | EOQ | 2026-07-25 |
| 307997 | 1836754522 | K243219 | MONARCH™ Platform (MON-000008) | EOQ | 2025-01-23 |
| 307997 | 1434563665 | K231473 | Monarch Bronchoscope | QNW | 2023-11-28 |
| 307997 | 1722187029 | K213334 | Monarch Platform, Urology | FGB | 2022-04-29 |
| 307997 | 1053666072 | K211493 | Monarch Platform | EOQ | 2021-07-09 |
| 307997 | 1924559901 | K203614 | Monarch Bronchoscope | QNW | 2021-03-11 |
| 307997 | 1017810595 | K193534 | Monarch Platform | EOQ | 2020-04-15 |
| 217904 | 1263618012 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | EOQ | 2018-03-22 |
| 218010 | 1263618012 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | EOQ | 2018-03-22 |
| 307997 | 1263618012 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | EOQ | 2018-03-22 |
| 307997 | 1223725904 | ||||
| 307997 | 1793892324 | ||||
| 307997 | 1932989262 |
Product Codes Associated With Registrations#
PMN#
Monarch Platform
Auris Health, Inc.
Monarch Platform
Auris Health, Inc.
GUDID#
MONARCH™ Advanced Imaging Accessory Kit - Window field generator and supplies
2026-06-02
MONARCH™ Navigation Sensors - Reusable navigation sensors
2026-05-27
Monarch Platform, Bronchoscopy - The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
2025-03-03
MONARCH™ Controller - Platform controller
2026-05-27
MONARCH™Platform, Urology - Monarch Tower, Cart, and Fluidics Pump
2026-05-05
Monarch® Ureteroscopy Kit - Ureteroscope and accessories
2026-05-05
Monarch®Platform Drape Kit - Equipment drapes
2026-05-05
MONARCH™ Kit Catheter & Accessories - Mini-PCNL Catheter, Percutaneous Sheath, dilation set and accessories.
2026-05-05
MONARCH™ Mini-PCNL Suction Set - Suction cartridge and tubing
2026-05-05
MONARCH™Guided Percutaneous Access Kit - Guided Percutaneous Access Needle and accessories
2026-05-04
MONARCH™ Stone Retrieval Basket - Stone retrieval basket and introducer
2026-05-04
MONARCH™ Urology Irrigation Cartridge - Irrigation cartridge and tubing
2026-05-04
MONARCH™ Ureteroscope Valve - Ureteroscope valve
2026-05-04
MONARCH™ Bronchoscope - Reprocessed Bronchoscope
2026-04-21
Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished - The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.Monarch Bronchscope 2.0/Monarch Platform (P2), refurbished.
2025-08-04
Monarch Platform, Bronchoscopy 4.1, Refurbished - The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. Refurbished.
2025-08-04
Monarch Advanced Imaging Accessory Kit - Window Field Generator, Connection Cable, Mounting System
2021-07-15
Monarch Bronchscope 2.0/Monarch Platform (P2) - The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.Monarch Bronchscope 2.0/Monarch Platform (P2)
2024-05-05
Monarch Endoscopy Platform (P1) System, Refurbished - MON-000005-01R
2020-03-25
Monarch Endoscopy Platform (P1) Tower Upgrade - MON-000005-01
2020-07-13
Monarch Endoscopy Platform (P1) Tower Upgrade - MON-000005-01
2020-03-25
Monarch Bronchscope 2.0/Monarch Platform (P2) - The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.Monarch Bronchscope 2.0/Monarch Platform (P2)
2020-04-21
Monarch™ Platform (Refurbished) - The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
2019-05-10
Monarch™ Platform - The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
2018-06-08
Extended Patient Introducer Mount - MON-000713
2025-09-04
Bronchoscope Fluidics Tubing - MBR-000218
2024-05-05
Monarch Bronchoscope - MBR-000211-A
2024-05-05
Bronchoscope Sheath Valve - MBR-000020
2024-05-05
Monarch™ Bronchoscope System - MBR-000011
2018-06-08
Aspirating Biopsy Needle - MBR-000012
2018-06-08
Biopsy Forceps - Smooth Cup - MBR-000014
2018-06-08
Cytology Brush - MBR-000015
2018-06-08
Navigation Patient Patches - Navigation Patient Patches (Quantity of 60)
2018-06-08
Bronchoscope Patient Introducer Kit - MBR-000017
2018-06-08
Bronchoscope Fluidics Tubing - MBR-000018
2018-06-08
Bronchoscope Valve - MBR-000019
2018-06-08
Monarch Bronchoscope - MBR-000211-A
2021-05-05
Monarch Bronchoscope - MBR-000211-B
2021-05-13
Monarch™ Tower Software v4.1.1 - Version 4.1.1
2025-06-04
Monarch™ Cart Software v4.1.1 - Version 4.1.1
2025-06-04