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MONARCH™ Advanced Imaging Accessory Kit MON-000709

by Auris Health, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810068810940 UDI-DI Date2 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1383-2026 FDA Class II initiated 21 Jan 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.

    • Ongoing Z-0051-2025 FDA Class II initiated 2 Aug 2024

    Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MONARCH™ Advanced Imaging Accessory Kit
Generic Name
Electromagnetic surgical tracking system field generator
Model / Ref / Catalog
MON-000709
Primary DI / UDI-DI
10810068810940
510(k) Number
FDA Product Code
EOQ, JAK
GMDN Term
Electromagnetic surgical tracking system field generator
Device Class
Class II
Regulation Number
874.4680, 892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K211493)

Show all (12)

Other devices from Auris Health, Inc.

See all devices from Auris Health, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No