FDA.reportPublic FDA data

Endoso

Primary DI
06975202770492
Brand
Endoso
Company
Hunan Endoso Life Technology Co., Ltd
Model
P2-B
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231107000Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.2024-02-15EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975202770492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975202770492069752027704926975202770492

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
722930494
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975202770287EndosoP1-A2025-11-28
06975202770294EndosoP1-B2025-11-28
06975202770300EndosoP1-C2025-11-28
06975202770317EndosoP1-D2025-11-28
06975202770478EndosoP1-E2025-11-28
06975202770485EndosoP2-A2025-11-28
06975202770508EndosoP2-C2025-11-28
06975202770515EndosoP2-D2025-11-28
06975202770522EndosoP2-E2025-11-28
06975202772878EndosoPUR12-S2025-11-28
06975202772908EndosoPUR12-42025-11-28
06975202772915EndosoPUR12-52025-11-28
06975202772922EndosoPUR12-62025-11-28
06975202772939EndosoPUR12-S12025-11-28
06975202772946EndosoPUR12-S22025-11-28
06975202773059EndosoPUR12-12025-11-28
06975202773073EndosoPUR12-32025-11-28
06975202773066EndosoPUR12-22025-11-26
06975202770102EndosoBC12-12024-07-12
06975202770119EndosoBC12-22024-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
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04719872715115MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
00856571007265EasyPath RF Introducer SheathBRONCUS MEDICAL INC.EOQ2026-04-23
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00850048825086Galaxy System (Cart) - RefurbishedNoah Medical CorporationEOQ2025-10-25
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
04048551446690N/AKarl Storz GmbH & Co. KGEOQ2023-08-14
10818634025118AmbuBosma EnterprisesEOQ2023-05-01
10818634025132AmbuBosma EnterprisesEOQ2023-05-01
10818634025156AmbuBosma EnterprisesEOQ2023-05-01
10818634025163AmbuBosma EnterprisesEOQ2023-05-01
00850023925206WiScope®Otu Medical Inc.EOQ2023-04-30