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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnetic Compression Anastomosis System
510(k) Number K253550
Device Name Self-Forming Magnet (Flexagon Plus OTOLoc)
Applicant
GI Windows, Inc.
381 University Ave.
Westwood,  MA  02090
Applicant Contact Westwood Bobay
Correspondent
GI Windows, Inc.
381 University Ave.
Westwood,  MA  02090
Correspondent Contact Westwood Bobay
Classification Product Code
SAH  
Date Received11/14/2025
Decision Date 01/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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