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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Bronchoscope (Non-Rigid)
510(k) Number K252921
Device Name Radial Jaw 4 Pulmonary Biopsy Forceps
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Elena Hennessey
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Elena Hennessey
Regulation Number874.4680
Classification Product Code
BWH  
Date Received09/12/2025
Decision Date 09/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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