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510(k) K982403

BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX by Brennen Medical, Inc. — Product Code PAG

K982403 is an FDA 510(k) premarket notification submitted by Brennen Medical, Inc. for the device "BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX". The FDA issued a decision of Substantially Equivalent on September 22, 1998. 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. Brennen Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
July 10, 1998
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 Brennen Medical, Inc.

  • K113866 — PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX (March 23, 2012)
  • K111436 — PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX (October 14, 2011)
  • K081272 — PORCINE SURGICAL MESH; DERMAL MATRIX (July 31, 2008)
  • K050086 — BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING (February 17, 2006)
  • K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (March 7, 2003)
  • K021835 — BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX (October 17, 2002)
  • K002078 — BETA GLUCAN GEL (MACROPRO GEL) (October 2, 2000)
  • K002077 — GLUCANPRO CREAM (October 2, 2000)
  • K000519 — GLUCANPRO (May 1, 2000)
  • K000518 — MACROPRO GEL (May 1, 2000)

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)
  • K993459 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (November 5, 1999)
  • K992159 — SURGISIS SLING (September 23, 1999)

FDA data resources