Cleared Special

K993459 - MODIFICATION TO BRENNEN BIOSYNTHETIC SU...

K993459 is an FDA 510(k) clearance for MODIFICATION TO BRENNEN BIOSYNTHETIC SU..., manufactured by Advanced Uroscience, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PAG cleared through the Special 510(k) pathway after a 23-day FDA review.

K993459 · Advanced Uroscience, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
23d
Days
Class 2
Risk

K993459 is an FDA 510(k) clearance for the MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX. Classified as Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code PAG), Class II - Special Controls.

Submitted by Advanced Uroscience, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 5, 1999 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Uroscience, Inc. devices

FDA 510(k) Submission Details - K993459

510(k) Number K993459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1999
Decision Date November 05, 1999
Days to Decision 23 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 130d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

PAG Device Classification - Class 2, Special Controls

Product Code PAG Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PAG Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Devices cleared under the same product code (PAG) and FDA review panel - the closest regulatory comparables to K993459.
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
K042949 · C.R. Bard, Inc. · Nov 2004
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
K031295 · C.R. Bard, Inc. · May 2003
STRATASIS SLING KIT
K020654 · Cook Biotech, Inc. · Apr 2002
SURGISIS SLING
K992159 · Cook Biotech, Inc. · Sep 1999