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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K252050
Device Name Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi
Tokyo,  JP 192-8507
Applicant Contact Seiko Yunoki
Correspondent
Olympus Corporation of the Americas
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Roshana Ahmed
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/01/2025
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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