FDA.reportPublic FDA data

Broncus Medical Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30078677783007867778Broncus Medical Inc1N2026-01-01125 Nicholson Ln San Jose CA US 95134

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1078861485860629K232601BroncTru™ Transbronchial Access ToolEOQ2024-05-31
1078861550722251K232038BioStar Single Use Transbronchial Aspiration NeedleEOQ2024-04-26
1078861701704858K200702EasyPath RF Introducer SheathEOQ2021-01-14
1078861415234571K183240Empower RF CatheterGEI2019-02-22
1078861355024382K133385LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARELLZ2014-02-26
1078861696222080K131234LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)EOQ2013-10-15
1078861775048966K093423LUNGPOINT PROCEDURE PLANNINGLLZ2009-11-17
1078861410340057K091160LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEMLLZ2009-05-05
1078861391844820K090853YIELD TISSUE SAMPLEREOQ2009-04-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EOQ52024-05-31
LLZ32014-02-26
GEI12019-02-22

PMN#

GUDID#

Archimedes System - Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedure Module offers real-time navigation guidance for use during the bronchoscopy procedure. The Software provides the option to segment previously acquired CT or other DICOM data sets and overlay and register these segmented data sets onto live fluoroscopic X-ray images. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.

BRONCUS MEDICAL INC.

2017-06-27

LungPoint VBN System, V3.2 - LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.

BRONCUS MEDICAL INC.

2017-06-27