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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K262044
Device Name Mediclose Cartridge System
Applicant
Health Value Creation B.V. (trading as Corporis Medical)
Oxfordlaan 55
Maastricht,  NL 6229 EV
Applicant Contact Alexander Veenhof
Correspondent
Creekside Regulatory Consulting, LLC
15644 Malta Way
Fishers,  IN  46037
Correspondent Contact Allison Scott
Regulation Number876.1500
Classification Product Code
OCW  
Subsequent Product Codes
GCJ   HCF  
Date Received06/17/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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