Monarch Platform

• • 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.

1. 9 Jul 2021 Cleared FDA 510(k) K211493
2. 2 Aug 2024 Recall initiated FDA recalls Z-0051-2025
3. 21 Jan 2026 Recall initiated FDA recalls Z-1383-2026

510(k) Number

K211493 ↗

FDA product code

EOQ

Device class

Class II

Regulation

21 CFR Part 874.4680

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

• Ultrasound Video Bronchoscope, Model EB-1970UK by Pentax Medical Company
• 10924E by Karl Storz SE & CO. KG
• Bronchoscope Accessory, NSN 6515-00-315-2200 by Delta Industries, Inc.
• Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor by Ambu A/S
• Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC, XBF-Q160Y2AC by Olympus Medical Systems Corporation
• 10316LR by Karl Storz SE & CO. KG
• Bronchoscope System by Shanghai AnQing Medical Instrument Co., Ltd
• FUJIFILM Endoscope Model EB-840S by FUJIFILM CORPORATION
• Flexible Biopsy Cup Forceps by SURGICAL TECHNOLOGIES, INC.
• Cannulated Biopsy Forceps by Thomasville Medical Assoc.

• MONARCH™ Navigation Sensors MON-000705 Open recall

  Class II

  FDA 510(k) K193534 Active Cleared 15 Apr 2020 GUDID on market

• MONARCH™ Controller MON-000706 Open recall

  Class II

  FDA 510(k) K193534 Active Cleared 15 Apr 2020 GUDID on market

• MONARCH™ Advanced Imaging Accessory Kit MON-000709 Open recall

  Class II

  FDA 510(k) K211493 Active Cleared 9 Jul 2021 GUDID on market

• MONARCH™Platform, Urology MON-000007 Open recall

  Class II

  FDA 510(k) K213334 Active Cleared 29 Apr 2022 GUDID on market

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