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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K260756
Device Name TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Applicant
Sentinel Medical Technologies,
50 N Laura St.
Suite 2500
Jacksonville,  FL  32202
Applicant Contact Jackelyn Rodriguez
Correspondent
Sentinel Medical Technologies,
50 N Laura St.
Suite 2500
Jacksonville,  FL  32202
Correspondent Contact Jackelyn Rodriguez
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
PHU  
Date Received03/09/2026
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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