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510(k) K090688

COOK UROLOGICAL GRAFT by Cook Biotech, Inc. — Product Code PAG

K090688 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "COOK UROLOGICAL GRAFT". The FDA issued a decision of Substantially Equivalent on July 10, 2009. 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. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2009
Date Received
March 16, 2009
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 Cook Biotech, Inc.

  • K133306 — SIS HERNIA GRAFT (July 23, 2014)
  • K133011 — DIAPHRAGMATIC HERNIA GRAFT (June 20, 2014)
  • K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT (October 8, 2013)
  • K111695 — HYBRID GRAFT (April 2, 2012)
  • K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER (June 20, 2011)
  • K082682 — SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (February 27, 2009)
  • K082058 — DYNAMATRIX (October 2, 2008)
  • K073391 — SURGISIS BIODESIGN TISSUE GRAFT (March 21, 2008)
  • K070405 — MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT (October 17, 2007)
  • K070738 — SIS FACIAL CYLINDER, SIS FACIAL IMPLANT (April 5, 2007)

Other clearances for product code PAG

  • 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)
  • 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