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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Device For Endoscopic Gastrointestinal Use
510(k) Number K261503
Device Name PuraStat GI
Applicant
3-D Matrix, Inc.
1234 Chestnut St., Suite 205
Newton,  MA  02464
Applicant Contact Alan MISKEWICZ
Correspondent
3-D Matrix, Inc.
1234 Chestnut St., Suite 205
Newton,  MA  02464
Correspondent Contact Alan MISKEWICZ
Regulation Number878.4456
Classification Product Code
QAU  
Date Received05/06/2026
Decision Date 08/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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