BroncTru Transbronchial Access Tool
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232601 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BroncTru Transbronchial Access Tool is a flexible bronchoscope accessory designed for transbronchial access procedures. It is intended to puncture the lung tissue, dilate the access site, and establish a working channel to facilitate the passage of additional endoscopic instruments to target lesions within the lung.
This device is supplied as a single-use instrument and is regulated under FDA 510(k) clearance (K232601) as a Class II moderate-risk medical device under the Ear, Nose, and Throat category. It is intended for use in conjunction with a flexible bronchoscope and adheres to regulatory standards outlined in 21 CFR 874. The device is identified by the product code EOQ and GUDID AK-82-70.
Frequently asked questions
What is the BroncTru Transbronchial Access Tool used for in clinical practice?
The BroncTru Transbronchial Access Tool is designed to assist in transbronchial access procedures, allowing clinicians to puncture lung tissue, dilate the access site, and create a working channel. This enables the passage of additional endoscopic instruments to reach and target lesions within the lung during bronchoscopy.
Is the BroncTru Transbronchial Access Tool intended for single-use or reusable applications?
The BroncTru Transbronchial Access Tool is explicitly supplied as a single-use instrument, meaning it is intended for one-time use only and should not be reused after a single procedure.
How is the BroncTru Transbronchial Access Tool regulated in the U.S.?
The device is classified as a Class II moderate-risk medical device under the Ear, Nose, and Throat (ENT) category and has received FDA 510(k) clearance (K232601). It is determined to be substantially equivalent to a predicate device and adheres to regulatory standards outlined in 21 CFR 874.
What other equipment is required to use the BroncTru Transbronchial Access Tool?
The BroncTru Transbronchial Access Tool is intended for use in conjunction with a flexible bronchoscope. It is not a standalone device and must be paired with a compatible bronchoscope for transbronchial access procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BroncTru™ Transbronchial Access Tool — FDA Class II Medical Device ..., BroncTru™ Transbronchial Access Tool (K232601) - Innolitics, K232601 - BroncTru Transbronchial Access Tool | FDA 510 (k), BroncTru™ Transbronchial Access Tool AK-82-70 GUDID… - FDA.report, PDF Antoinette M. Clay 125 Nicholson Lane Regulation Number: 21 CFR 874. ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232601 | Class II | Active |
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Manufacturer
- Manufacturer
- Broncus Medical Inc.
- FDA Applicant
- Broncus Medical, Inc.
Sources (1)
- FDA 510(k) K232601 24 fields · synced Sep 19, 2026