Monarch Endoscopy Controller MON-000712
Monarch Endoscopy Controller MON-000712 is an endoscopic control/video-imaging system (FDA Class II) made by Auris Health, Inc., cleared under FDA 510(k) K243219 on 23 Jan 2025 and listed in FDA GUDID since 5 Mar 2025 (UDI-DI 10810068810971), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10810068810971 | Date5 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243219 | Date23 Jan 2025 | StatusActive |
Official records
- AccessGUDID record 10810068810971
- FDA 510(k) database K243219
Across registries
- FDA 510(k) K243219 decided 23 Jan 2025 Active
- FDA GUDID UDI-DI 10810068810971 listed 5 Mar 2025 Listed
Recalls
-
- Ongoing Z-1383-2026
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 position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
Timeline
- Cleared FDA 510(k) K243219
- Listed FDA GUDID 10810068810971
- Recall initiated FDA recalls Z-1383-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Monarch Endoscopy Controller
- Generic name
- Endoscopic control/video-imaging system
- Model / reference
- MON-000712
- Primary DI / UDI-DI
- 10810068810971
- 510(k) Number
- FDA product code
- EOQ, JAK
- GMDN term
- Endoscopic control/video-imaging system
- Device class
- Class II
- Regulation number
- 874.4680, 892.1750
- GUDID distribution status
- In Commercial Distribution
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