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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 K222293
Device Name ArcSP Suprapubic Sling System
Applicant
Urocure, LLC
701 N. 3rd St., Suite 110
Minneapolis,  MN  55401
Applicant Contact John Nelson
Correspondent
Libra Medial, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact Denise Lenz
Regulation Number878.3300
Classification Product Code
OTN  
Date Received08/01/2022
Decision Date 09/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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