Identity
- Trade Name
- Monarch™ Tower Software v4.1.1 FDA UDI
- Generic Name
- Robotic surgical system application software FDA UDI
- Device Name
- Monarch™ Tower Software v4.1.1 FDA UDI
- Model / Reference
- Version 4.1.1 FDA UDI
- Description
- Monarch™ Tower Software v4.1.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810068811497 FDA UDI
- 510(k) Number
- K243219 FDA UDI
- FDA Product Code
- EOQ FDA UDIJAK FDA UDI
- GMDN Term
- Robotic surgical system application software 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Robotic surgical system application software
Monarch™ Tower Software v4.1.1 by Auris Health, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical system application software.
- iotaSOFT Insertion System — Iotamotion, Inc. · Class II
- Monarch Software Tower v2.2.1 — Auris Health, Inc. · Class II
- iotaSOFT Insertion System — Iotamotion, Inc. · Class II
- Monarch™ Software Tower v2.1.2 — Auris Health, Inc. · Class II
- ELMED — ELMED INCORPORATED · Class I
- ApolloHipX — CORIN LTD · Class II
- ELMED — ELMED INCORPORATED · Class I
- iotaSOFT Insertion System — Iotamotion, Inc. · Class II
Cleared under the same submission
K243219 also covers:
- Monarch Platform, Bronchoscopy 4.1, Refurbished — Auris Health, Inc
- Monarch™ Cart Software v4.1.0 — Auris Health, Inc
- Monarch™ Cart Software v4.1.1 — Auris Health, Inc
- Monarch™ Laptop P16 Software v4.1.1 — Auris Health, Inc
- Monarch™ Laptop P17 Software v4.1.0 — Auris Health, Inc
- Monarch™ Laptop P17 Software v4.1.1 — Auris Health, Inc
- Monarch™ Tower Software v4.1.0 — Auris Health, Inc
- Extended Patient Introducer Mount — Auris Health, Inc.
- Monarch Endoscopy Controller — Auris Health, Inc.
- Monarch Platform, Bronchoscopy 4.1 — Auris Health, Inc.
- Monarch™ Laptop P16 Software v4.1.0 — 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 9805db78-3f37-422b-86eb-c8325f360e83 34 fields · synced Jun 4, 2026