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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name biopsy needle
510(k) Number K160098
Device Name Single Use Aspiration Needle NA-U401SX
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ISHIKAWA-CHO
HACHIOJI-SHI,  JP 192-8507
Applicant Contact TOSHIYUKI NAKAJIMA
Correspondent
OLYMPUS CORPORATION OF THE AMERICAS
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact SHERI L. MUSGNUNG
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/19/2016
Decision Date 03/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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