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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
510(k) Number K262284
Device Name KIM BLUE
Applicant
Desarrollo e Investigación Médica Aragonesa S.L.
Polígono Industrial Mediavega, Parcela 2.8
Calatayud,  ES 50300
Applicant Contact Francisco Farrer Velázquez
Correspondent
Desarrollo e Investigación Médica Aragonesa S.L.
Polígono Industrial Mediavega, Parcela 2.8
Calatayud,  ES 50300
Correspondent Contact Andrea Portaña Sanz
Regulation Number878.3300
Classification Product Code
OTN  
Date Received07/06/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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