What is FDA product code EOQ?

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Ear Nose & Throat › SurgicalBronchoscope (Flexible Or Rigid)

Monarch™ Software Laptop V2.1.5

Name: Monarch™ Software Laptop v2.1.5
Brand: Monarch™ Software Laptop v2.1.5

Catalogue number Version 2.1.5, listed by Auris Health, Inc, United States, under Bronchoscope (Flexible Or Rigid). 21 manufacturers in China are registered for this product code.

Registry build 21.09.26

21manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

6recalls on this code

Who Else Makes It

Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EOQ
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
Guangdong MacroLux Medical Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	9
Ningbo Wise Optomech Technology Corporation	Ningbo	Zhejiang	Contract manufacturer	4
Hangzhou Broncus Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	1
Tianjin Puli Ark Medical Technology Co., Ltd.	Dongli District	Tianjin	Contract manufacturer	1
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Zhejiang Huanyi Sterilization Technology Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	25
Shenzhen Hugemed Medical Technical Development Co., Ltd.	Shenzhen	Guangdong	Manufacturer	22
Suzhou Prosteri Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Suzhou Virgil Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Anrei Medical (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	12

Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)

Record

Regulatory record for Monarch™ Software Laptop v2.1.5
Listed by	Auris Health, Inc, United States
FDA product code	EOQ
Device type	Bronchoscope (Flexible Or Rigid)
Device class	Class 2
Regulation	21 CFR 874.4680
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K173760
Record published	2019-09-10
Record revised	2025-09-01 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only

Catalogue Numbers

Catalogue numbers for Monarch™ Software Laptop v2.1.5
Catalogue number	Size	Status
Version 2.1.5		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bronchoscope (Flexible Or Rigid)	Karl Storz GmbH & Co. KG	248
Pentax	Hoya Corporation	39
Biopsy Forceps	Olympus Medical Systems Corp.	31
Single-Use flexible Video Bronchoscope	Hunan Vathin Medical Instrument Co., Ltd.	27
Pilling	Teleflex Medical LLC	24
Silicone cap	Efer Endoscopy	22
Bronchoscope (Flexible Or Rigid)	Intuitive Surgical, Inc.	20
Endoso	Hunan Endoso Life Technology Co., Ltd.	20
Exalt ™	Boston Scientific Corporation	17
Grasping Forceps	Olympus Medical Systems Corp.	16
LungVision Tool	Body Vision Medical Ltd	16
Fujifilm	Fujifilm Corporation	15

Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260382	2026-07-25
K243219	2025-01-23
K211493	2021-07-09
K193534	2020-04-15

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Monarch™ Software Laptop v2.1.5
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Auris Health, Inc	510(k) number	2019-04-19	Class II	Labeling design	Reports of aspirating biopsy needle breakage	158	2022-01-19

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-01-21	Class II	Software design	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 pos	173
2024-08-02	Class II	Device Design	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	176
2023-10-18	Class II	Software design	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.	110 units In total
2023-10-18	Class II	Software design	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.	110 units In total
2023-10-18	Class II	Software design	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.	110 units In total

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.