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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K232038
Device Name BioStar Single Use Transbronchial Aspiration Needle
Applicant
Broncus Medical, Inc.
125 Nicholson Ln.
San Jose,  CA  95134
Applicant Contact Charles Ogbonna
Correspondent
Broncus Medical, Inc.
125 Nicholson Ln.
San Jose,  CA  95134
Correspondent Contact Antoinette Clay
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received07/10/2023
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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