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510(k) K993459

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX by Advanced Uroscience, Inc. — Product Code PAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1999
Date Received
October 13, 1999
Clearance Type
Special
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 Advanced Uroscience, Inc.

  • K001807 — TISSUE MARKER (May 3, 2001)
  • K002573 — ADVANCED UROSCIENCE INNERSHEATH (November 16, 2000)
  • K002323 — ADVANCED UROSCIENCE INJECTION NEEDLE (July 31, 2000)
  • K982890 — ADVANCED UROSCIENCE INJECTION NEEDLE (October 26, 1998)

Other clearances for product code PAG

  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K050445 — AMS COLLAGEN DERMAL MATRIX (June 17, 2005)
  • K042949 — PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) (November 9, 2004)
  • 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)
  • K992159 — SURGISIS SLING (September 23, 1999)
  • K982403 — BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (September 22, 1998)