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510(k) K052401

GYNECARE TVT SECUR SYSTEM by Ethicon, Inc. — Product Code PAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2005
Date Received
September 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

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  • K110420 — OPHIRA MINI SLING SYSTEM (May 8, 2012)
  • K103418 — DESARA MINI (November 30, 2011)
  • K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (June 7, 2010)
  • K092607 — AJUST ADJUSTABLE SINGLE INCISION SLING (November 20, 2009)