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FDA 510(k)

BioStar Single Use Transbronchial Aspiration Needle

K-Number: K232038 · 2024-04-26

ApplicantBroncus Medical, Inc.
Decision Date2024-04-26
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BioStar Single Use Transbronchial Aspiration Needle is a medical device manufactured by Broncus Medical, Inc.. It received FDA 510(k) clearance on 2024-04-26 under approval number K232038. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioStar Single Use Transbronchial Aspiration Needle?

BioStar Single Use Transbronchial Aspiration Needle is a medical device that received FDA 510(k) clearance on 2024-04-26. It is manufactured by Broncus Medical, Inc.. The 510(k) number is K232038.

When was BioStar Single Use Transbronchial Aspiration Needle approved by the FDA?

BioStar Single Use Transbronchial Aspiration Needle received FDA 510(k) clearance on 2024-04-26, under approval number K232038.

What company makes BioStar Single Use Transbronchial Aspiration Needle?

BioStar Single Use Transbronchial Aspiration Needle is manufactured by Broncus Medical, Inc..

What is the FDA product code for BioStar Single Use Transbronchial Aspiration Needle?

The FDA product code for BioStar Single Use Transbronchial Aspiration Needle is EOQ.

Related Clinical Trials

NCT02299102 Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures COMPLETED NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT07577232 Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Broncus Medical, Inc.

K183240Empower RF Catheter K200702EasyPath RF Introducer Sheath K232601BroncTru™ Transbronchial Access Tool K260009LungPoint Virtual Bronchoscopic Navigation (VBN) Software

Related Devices (Code: EOQ)

K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView MonitorAmbu A/S K152319Auris Robotic Endoscopy System (ARES)Auris Surgical Robotics, Inc. K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)Prosurg, Inc. K171492B7 2C Occlusion BalloonSpiration, Inc. K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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