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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K253598
Device Name InjecSURE Injection System
Applicant
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact Jared Klein
Correspondent
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact Jared Klein
Regulation Number876.1500
Classification Product Code
FBK  
Date Received11/18/2025
Decision Date 03/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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