# K232601: BroncTru™ Transbronchial Access Tool

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Medical, Inc.
- Decided: May 31, 2024 after 277 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931154 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142934: CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved, Covidien (2015) Summary page 6.
- K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon), Broncus Medical, Inc. (2013) Summary page 6.

## Indications for use
The BroncTru Transbronchial Access Tool is indicated for use in conjunction with a flexible bronchoscope to puncture the lung, dilate, and establish a working channel, facilitating the guidance of other endoscopic tools to reach target lesions.

Source page: https://510kreport.com/device/K232601
Methodology: https://510kreport.com/methodology