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.…
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.
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Hangzhou Broncus Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 1 |
| Tianjin Puli Ark Medical Technology Co., Ltd. | Dongli District | Tianjin | Contract manufacturer | 1 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)
Record
| Listed by | Auris Health, Inc, United States |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K211493 |
| Record published | 2025-08-04 |
| Record revised | 2026-03-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Crate |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MON-000006-RFB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 248 |
| Pentax | Hoya Corporation | 39 |
| Biopsy Forceps | Olympus Medical Systems Corp. | 31 |
| Single-Use flexible Video Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 27 |
| Pilling | Teleflex Medical LLC | 24 |
| Silicone cap | Efer Endoscopy | 22 |
| Bronchoscope (Flexible Or Rigid) | Intuitive Surgical, Inc. | 20 |
| Endoso | Hunan Endoso Life Technology Co., Ltd. | 20 |
| Exalt ™ | Boston Scientific Corporation | 17 |
| Grasping Forceps | Olympus Medical Systems Corp. | 16 |
| LungVision Tool | Body Vision Medical Ltd | 16 |
| Fujifilm | Fujifilm Corporation | 15 |
Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260382 | 2026-07-25 |
| K243219 | 2025-01-23 |
| K211493 | 2021-07-09 |
| K193534 | 2020-04-15 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Auris Health, Inc | 510(k) number | 2026-01-21 | Class II | Software design | Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right pos | 173 |
| Auris Health, Inc | 510(k) number | 2024-08-02 | Class II | Device Design | Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and | 176 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-10-18 | Class II | Software design | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. | 110 units In total | |
| 2023-10-18 | Class II | Software design | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. | 110 units In total | |
| 2023-10-18 | Class II | Software design | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. | 110 units In total | |
| 2019-04-19 | Class II | Labeling design | Reports of aspirating biopsy needle breakage | 158 | 2022-01-19 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.