Broncus Medical Inc
San Jose, CA, US
Broncus Medical Inc appears in FDA device records in San Jose, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Broncus Medical Inc between 2013 and 2026. The busiest year on record is 2024, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | LLZ | Substantially Equivalent | |
| K232601 | BroncTru™ Transbronchial Access Tool | EOQ | Substantially Equivalent | |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | EOQ | Substantially Equivalent | |
| K200702 | EasyPath RF Introducer Sheath | EOQ | Substantially Equivalent | |
| K183240 | Empower RF Catheter | GEI | Substantially Equivalent | |
| K133385 | LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE | LLZ | Substantially Equivalent | |
| K131234 | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) | EOQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007867778 | 3007867778 | Broncus Medical Inc | 125 Nicholson Ln, San Jose, CA 95134 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain