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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
510(k) Number K260380
Device Name Mendit
Applicant
Escala Medical, Ltd.
17 Ha’Tchelet St.
Misgav Business Park
Misgav,  IL 2017400
Applicant Contact Edit Goldberg
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number884.4530
Classification Product Code
PBQ  
Date Received02/05/2026
Decision Date 03/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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