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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 K052175
Device Name I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
Applicant
Uroplasty, Inc.
2718 Summer St. NE
Minneapolis,  MN  55413
Applicant Contact MICHAEL MORRELL
Correspondent
Uroplasty, Inc.
2718 Summer St. NE
Minneapolis,  MN  55413
Correspondent Contact MICHAEL MORRELL
Regulation Number878.3300
Classification Product Code
OTN  
Date Received08/10/2005
Decision Date 10/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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