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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 K250957
Device Name Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi
Tokyo,  JP 192-8507
Applicant Contact Seiko Yunoki
Correspondent
Olympus Surgical Techologies of America
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Susan Lewandowski
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received03/31/2025
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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