FDA.reportPublic FDA data

BroncTru™ Transbronchial Access Tool

Primary DI
00856571007975
Brand
BroncTru™ Transbronchial Access Tool
Company
BRONCUS MEDICAL INC.
Model
AK-46-00
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K232601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232601000BroncTru™ Transbronchial Access ToolBroncus Medical, Inc.2024-05-31EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856571007972PackageGS11In Commercial Distribution
00856571007975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085657100797210856571007972
00856571007975008565710079758565710079750856571007975

GMDN Terms#

Term, Definition table
TermDefinition
Bronchoscopic catheterA sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078684808
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856571007265EasyPath RF Introducer Sheath100112026-04-23
00856571007913BroncTru™ Transbronchial Access ToolAK-82-702025-03-31
00856571007920BroncTru™ Transbronchial Access ToolAK-64-602025-03-31
00856571007937BroncTru™ Transbronchial Access ToolAK-46-552025-03-31
00856571007944BroncTru™ Transbronchial Access ToolAK-91-552025-03-31
00856571007951BroncTru™ Transbronchial Access ToolAK-82-002025-03-31
00856571007968BroncTru™ Transbronchial Access ToolAK-64-002025-03-31
00856571007982BroncTru™ Transbronchial Access ToolAK-91-002025-03-31
08565710078012BioStar Transbronchial Aspiration NeedleiS2372024-08-19
08565710078029BioStar Transbronchial Aspiration NeedleiS2272024-08-19
00856571007296Archimedes Access Kit10009-910009-92021-10-04
00856571007241Empower RF Catheter10010100102019-11-01
00856571007036Archimedes System40005400052017-06-27
00856571007104Archimedes Planning System40009400092017-06-27
00856571007128LungPoint Planning System, v3.230009300092017-06-27
00856571007173LungPoint VBN System, V3.230005300052017-06-27
00856571007227Archimedes Access Key10009-110009-12017-12-12
00856571007258Archimedes Access Key, 10-pack10009-210009-22019-02-21
00856571007012FleXNeedle10005-110005-12017-05-12
00856571007029Archimedes Access Kit10009100092017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.EOQ2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
04719872715108MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
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