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MONARCH™ Navigation Sensors MON-000705

by Auris Health, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

4 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 Number10810068810841 UDI-DI Date27 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · 4 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.

  • 3 recalls, same reason

    • Ongoing Z-0448-2024 FDA Class II initiated 18 Oct 2023
    • Ongoing Z-0449-2024 FDA Class II initiated 18 Oct 2023
    • Ongoing Z-0450-2024 FDA Class II initiated 18 Oct 2023

    Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MONARCH™ Navigation Sensors
Generic Name
Electromagnetic surgical navigation/tracking system
Model / Ref / Catalog
MON-000705
Primary DI / UDI-DI
10810068810841
510(k) Number
FDA Product Code
EOQ, JAK
GMDN Term
Electromagnetic surgical navigation/tracking system
Device Class
Class II
Regulation Number
874.4680, 892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K193534)

Other devices from Auris Health, Inc.

See all devices from Auris Health, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

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