Identity
- Trade Name
- Monarch™ Platform FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. FDA UDI
- Model / Reference
- MON000005 FDA UDI
- Description
- The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. FDA UDI
Identifiers
- Catalog Number
- MON000005 FDA UDI
- Primary DI / UDI-DI
- B634MON0000050 FDA UDI
- 510(k) Number
- K173760 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™ Platform 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
- Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
Cleared under the same submission
K173760 also covers:
- Biopsy Forceps - Smooth Cup — Auris Health, Inc
- Bronchoscope Fluidics Tubing — Auris Health, Inc
- Bronchoscope Patient Introducer Kit — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Valve — Auris Health, Inc
- Cytology Brush — Auris Health, Inc
- Monarch Endoscopy Platform (P1) Tower Upgrade — Auris Health, Inc
- Monarch Software Laptop v2.1.6 — Auris Health, Inc
- Monarch Software Laptop v2.2.1 — Auris Health, Inc
- Monarch Software Tower v2.1.6 — Auris Health, Inc
- Monarch™ Bronchoscope System — 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 9f53d854-565d-454d-ad0f-035ac9b0fd8b 35 fields · synced Jun 4, 2026