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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Dead Space Piston Syringe
510(k) Number K250127
Device Name TSK Syringe
Applicant
Tsk Laboratory, Japan
1510-1, Soja-Machi, Tochigi-Shi
Tochigi-Ken,  JP 328-0002
Applicant Contact Yumi Ueda
Correspondent
Namsa
400 Hwy. 169 S.
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Anna Galea
Regulation Number880.5860
Classification Product Code
QNQ  
Subsequent Product Code
FMF  
Date Received01/17/2025
Decision Date 07/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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