Data / Medical devices / United States / Broncus Medical Inc

Broncus Medical Inc: FDA-registered device maker in San Jose, CA, United States, 9 510(k) clearances

Name: Broncus Medical Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Broncus Medical Inc is registered with the FDA (registration 3007867778) in San Jose, CA, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 31, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007867778
Address: 125 Nicholson Ln, San Jose, CA, United States, 95134
Owner or operator: Broncus Medical, Inc. (10030260)
Roles: Manufacturer
First device listed: September 3, 2009
Registered through: 2026
Brand names listed: Archimedes Access Kit, Archimedes Dilation Balloon, Archimedes Sheath, Archimedes System, BioStar® Transbronchial Aspiration Needle, BroncTru Transbronchial Access Tool, EMPOWER RF Catheter, EasyPath RF Introducer Sheath and more

Devices it lists

Device	Product code	Class	Role	Source
Bronchoscope (Flexible Or Rigid)	EOQ	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 31, 2024	K232601	BroncTru Transbronchial Access Tool	EOQ	Substantially Equivalent	Broncus Medical, Inc.	accessdata.fda.gov
April 26, 2024	K232038	BioStar Single Use Transbronchial Aspiration Needle	EOQ	Substantially Equivalent	Broncus Medical, Inc.	accessdata.fda.gov
January 14, 2021	K200702	EasyPath RF Introducer Sheath	EOQ	Substantially Equivalent	Broncus Medical, Inc.	accessdata.fda.gov
February 22, 2019	K183240	Empower RF Catheter	GEI	Substantially Equivalent	Broncus Medical, Inc.	accessdata.fda.gov
February 26, 2014	K133385	LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE	LLZ	Substantially Equivalent	Broncus Medical, Inc.	accessdata.fda.gov
October 15, 2013	K131234	LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)	EOQ	Substantially Equivalent	Broncus Medical, Inc.	accessdata.fda.gov
November 17, 2009	K093423	LUNGPOINT PROCEDURE PLANNING	LLZ	Substantially Equivalent	Broncus Technologies, Inc.	accessdata.fda.gov
May 5, 2009	K091160	LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM	LLZ	Substantially Equivalent	Broncus Technologies, Inc.	accessdata.fda.gov
April 7, 2009	K090853	YIELD TISSUE SAMPLER	EOQ	Substantially Equivalent	Broncus Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 31, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.