Identity
- Trade Name
- Monarch Bronchscope 2.0/Monarch Platform (P2) FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- MON-000006 FDA UDI
- 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. Monarch Bronchscope 2.0/Monarch Platform (P2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810068810803 FDA UDI
- 510(k) Number
- K211493 FDA UDI
- FDA Product Code
- EOQ FDA UDIJAK FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Robotic surgical arm system
Monarch Bronchscope 2.0/Monarch Platform (P2) by Auris Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
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- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
Cleared under the same submission
K211493 also covers:
- Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished — Auris Health, Inc
- Monarch™ Laptop P17/P73 Linux USB Image v2.2.4 — Auris Health, Inc
- Monarch™ Laptop P70 Linux USB Image v2.2.4 — Auris Health, Inc
- Monarch™ Laptop P70 Linux USB Image v2.2.5 — Auris Health, Inc
- Monarch™ Software Cart v2.2.4 — Auris Health, Inc
- Monarch™ Software Cart v2.2.5 — Auris Health, Inc
- Monarch™ Software Tower v2.2.4 — Auris Health, Inc
- Monarch™ Software Tower v2.2.5 — Auris Health, Inc
- Monarch Advanced Imaging Accessory Kit — Auris Health, Inc.
- Monarch™ Laptop P17/P73 Linux USB Image v2.2.5 — Auris Health, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Auris Health, Inc.
Sources (1)
- FDA UDI c51b430a-4f56-4bb0-af7c-1b3b03a138e8 34 fields · synced Jun 8, 2026