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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Syringe
510(k) Number K243936
Device Name StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
Applicant
Staclear, Inc.
7250 Acc Blvd.
Raleigh,  NC  27617
Applicant Contact Jackson Thornton
Correspondent
Staclear, Inc.
7250 Acc Blvd.
Raleigh,  NC  27617
Correspondent Contact Jackson Thornton
Regulation Number880.5860
Classification Product Code
QLY  
Subsequent Product Codes
FMF   FMI  
Date Received12/20/2024
Decision Date 04/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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