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BioStar Single Use Transbronchial Aspiration Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232038

by Broncus Medical Inc.

Identifiers

510(k) Number
K232038 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 BioStar Single Use Transbronchial Aspiration Needle is a sterile single-use disposable catheter with a coring needle in a protective sheath that directly connects to standard flexible optical bronchoscopes with a working channel of not less than 1.7 mm. It is designed for transbronchial aspiration procedures.

The device is supplied sterile and intended for single-use only. It received FDA 510(k) clearance under K232038 on April 26, 2024, and is classified under product code EOQ. It was reviewed by the ENT advisory committee and determined to be substantially equivalent.

Frequently asked questions

What is the BioStar Single Use Transbronchial Aspiration Needle used for?

The BioStar Single Use Transbronchial Aspiration Needle is designed for transbronchial aspiration procedures, allowing clinicians to obtain samples from lung tissue through the bronchial wall using a flexible bronchoscope with a working channel of not less than 1.7 mm.

How is the BioStar Single Use Transbronchial Aspiration Needle supplied and is it reusable?

The device is supplied sterile and intended for single-use only; it must not be reused, reprocessed, or resterilized due to the risk of contamination, material degradation, and compromised performance after initial use.

What bronchoscopes is the BioStar Single Use Transbronchial Aspiration Needle compatible with?

It directly connects to standard flexible optical bronchoscopes that have a working channel diameter of not less than 1.7 mm, ensuring secure attachment and reliable function during transbronchial aspiration 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: BioStar Single Use Transbronchial Aspiration Needle, BioStar Transbronchial Aspiration Needle 08565710078029 Medical Device ..., BioStar Single Use Transbronchial Aspiration Needle, BRONCUS MEDICAL INC. iS237 BioStar Transbronchial Aspiration Needle

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Broncus Medical Inc.
FDA Applicant
Broncus Medical, Inc.

Sources (1)

  • FDA 510(k) K232038 24 fields · synced Sep 21, 2026