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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 K250262
Device Name GO-PEN®
Applicant
Go-Pen Aps
Diplomvej 381
C/O Dtu Science Park
Kongens Lyngby,  DK 2800
Applicant Contact Ole Nielsen
Correspondent
Veranex
5420 Wade Park Blvd., Suite 204
Raleigh,  NC  27607
Correspondent Contact Paige Sutton-Smith
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/29/2025
Decision Date 04/24/2025
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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