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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K260208
Device Name Ultra-Fine™ SAFETY Insulin Syringe
Applicant
embecta Medical II, LLC
300 Kimball Dr.
Parsippany,  NJ  07054
Applicant Contact Ewelina Rog
Correspondent
embecta Medical II, LLC
300 Kimball Dr.
Parsippany,  NJ  07054
Correspondent Contact Ewelina Rog
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MEG  
Date Received01/23/2026
Decision Date 07/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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