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510(k) K260380

Mendit by Escala Medical, Ltd. — Product Code PBQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 4, 2026
Date Received: February 5, 2026
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Device Class: Class II
Regulation Number: 884.4530
Review Panel: OB
Submission Type

Attaching suture or stapling ligaments of the pelvic floor.