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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K252908
Device Name Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
Applicant
Sandstone Medical (Suzhou), Inc.
#168 Putuoshan Rd., New District
Suzhou,  CN 215253
Applicant Contact Susan Sun
Correspondent
Sandstone Medical (Suzhou), Inc.
#168 Putuoshan Rd., New District
Suzhou,  CN 215253
Correspondent Contact Susan Sun
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/12/2025
Decision Date 03/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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