# Monarch Endoscopy Controller MON-000712

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/monarch-endoscopy-controller-mon-000712>
- Manufacturer: [Auris Health, Inc.](https://devicerts.com/manufacturers/auris-health-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: EOQ, JAK
- GMDN: Endoscopic control/video-imaging system (47140)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 10810068810971 · listed 2025-03-05 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K243219 · decision 2025-01-23 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1383-2026 · Class II · ongoing · initiated 2026-01-21: 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.

## Identity

- Trade name: Monarch Endoscopy Controller [FDA GUDID (AccessGUDID)]
- Generic name: Endoscopic control/video-imaging system [FDA GUDID (AccessGUDID)]
- Model / reference: MON-000712 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10810068810971 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K243219 [FDA GUDID (AccessGUDID)]
- FDA product code: EOQ [FDA GUDID (AccessGUDID)]; JAK [FDA GUDID (AccessGUDID)]
- GMDN term: Endoscopic control/video-imaging system (47140) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 874.4680 [FDA GUDID (AccessGUDID)]; 892.1750 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Monarch Endoscopy Controller MON-000712, Auris Health, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/monarch-endoscopy-controller-mon-000712 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/monarch-endoscopy-controller-mon-000712.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/monarch-endoscopy-controller-mon-000712
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.