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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K251664
Device Name Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Jillian Connery
Correspondent
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Correspondent Contact Jillian Connery
Regulation Number874.4680
Classification Product Code
KTI  
Date Received05/30/2025
Decision Date 07/29/2025
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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