Monarch Software Tower v2.2.1 Version 2.2.1
Monarch Software Tower v2.2.1 Version 2.2.1 is a robotic surgical system application software (FDA Class II) made by Auris Health, Inc., cleared under FDA 510(k) K173760 on 22 Mar 2018 and listed in FDA GUDID since 5 Mar 2020 (UDI-DI B634SW0121920202000), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB634SW0121920202000 | Date5 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173760 | Date22 Mar 2018 | StatusActive |
Official records
- FDA 510(k) database K173760
Across registries
- FDA 510(k) K173760 decided 22 Mar 2018 Active
- FDA GUDID UDI-DI B634SW0121920202000 listed 5 Mar 2020 Listed
Recalls
-
- Terminated Z-0025-2020
Reports of aspirating biopsy needle breakage
Timeline
- Cleared FDA 510(k) K173760
- Recall initiated FDA recalls Z-0025-2020
- Listed FDA GUDID B634SW0121920202000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Monarch Software Tower v2.2.1
- Generic name
- Robotic surgical system application software
- Model / reference
- Version 2.2.1
- Primary DI / UDI-DI
- B634SW0121920202000
- 510(k) Number
- FDA product code
- EOQ, JAK
- GMDN term
- Robotic surgical system application software
- Device class
- Class II
- Regulation number
- 874.4680, 892.1750
- GUDID distribution status
- In Commercial Distribution
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