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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 K261630
Device Name GI Windows Flexagon Plus OTOLoc System
Applicant
GI Windows Surgical
480 Neponset St.
Suite 11-B1
Canton,  MA  02021
Applicant Contact Yverre Bobay
Correspondent
GI Windows Surgical
480 Neponset St.
Suite 11-B1
Canton,  MA  02021
Correspondent Contact Yverre Bobay
Classification Product Code
SAH  
Date Received05/18/2026
Decision Date 10/28/2026
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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