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510(k) K042949

PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) by C.R. Bard, Inc. — Product Code PAG

K042949 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)". The FDA issued a decision of Substantially Equivalent on November 9, 2004. The device falls under product code PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator), a Class II device regulated under 21 CFR 878.3300. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2004
Date Received
October 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
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.

Other clearances by C.R. Bard, Inc.

  • K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blake (July 10, 2026)
  • K254076 — BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (May 29, 2026)
  • K252971 — Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (La (March 17, 2026)
  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K230356 — Aspirex™ Thrombectomy System (March 31, 2023)
  • K223177 — Highlander™ 014 PTA Balloon Dilatation Catheter (January 20, 2023)
  • K222793 — WavelinQ™ Generator (October 17, 2022)
  • K220270 — Aspirex Thrombectomy System (June 21, 2022)

Other clearances for product code PAG

  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K050445 — AMS COLLAGEN DERMAL MATRIX (June 17, 2005)
  • K031295 — BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM (May 15, 2003)
  • K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (March 7, 2003)
  • K020654 — STRATASIS SLING KIT (April 9, 2002)
  • K993459 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (November 5, 1999)
  • K992159 — SURGISIS SLING (September 23, 1999)
  • K982403 — BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (September 22, 1998)

FDA data resources