510(k) Report

510(k) · Cleared

Cleared

Brennen Biosynthetic Surgical Mesh Matrix

K982403510(k) TraditionalCleared Sep 22, 199874-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Brennen Medical, Inc. · PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Sep 22, 1998 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 41 later devices descend from it.

Decided
Sep 22, 1998
Review
74 days
Class
Class II
Product code
PAG
Recalls
None
Predicates
0

41 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared1999: 1 descendant cleared2011: 3 descendants cleared2008: 7 descendants cleared2002: 1 descendant cleared2005: 2 descendants cleared2014: 2 descendants cleared2012: 4 descendants cleared2006: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2007: 1 descendant cleared2009: 2 descendants cleared2013: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2025: 3 descendants cleared2026: 3 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK982403 Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 1998
  2. Descendant · cites it directly · 40 of its ownK993459 Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc. · 1999
  3. Descendant · 2 generations on · 38 of its ownK021160 Dermmatrix Surgical MeshCarbon Medical Technologies, Inc. · 2002
  4. Descendant · 3 generations on · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
  5. Descendant · 4 generations on · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
  6. Descendant · 4 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

1999: 12002: 12003: 12005: 22006: 12007: 12008: 72009: 22011: 32012: 42013: 12014: 22015: 12016: 32022: 22023: 22024: 12025: 32026: 3
1999high 7 (2008) · low 0 (2000)2026

Most influential descendants

Showing 5 of 41 · See all
  • K993459Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc. · 1999 · cites it directly40descendants
  • K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc. · 2002 · 2 generations on38descendants
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · 3 generations on30descendants
  • K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · 4 generations on17descendants
  • K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 4 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K982403Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc.1998—
+1K993459Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc.1999—
+2K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.2002—
+3K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.20051
+4K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.2005—
+4K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal…American Medical Systems, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200310
200520
200610
200710
200870
200920
201130
201240
201310
201420
201510
201630
202220
202320
202410
202530
202630
FIG. 1 — Lineage of K982403, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PAG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (41)

See all 41

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993459Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc.199940
K030460Modification to Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc.20037

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K993459 (Advanced Uroscience, Inc., 1999) has gone furthest, with 40 descendants of its own.

How does its category compare?

All PAG devices

PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PAG

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAG

Too few PAG 510(k)s in any year since 2007 to give a median.

Recalls per year · PAG

No recall names PAG since 2007.

Adverse event reports per year · PAG

1in 2023

2008: 12013: 842014: 2562015: 732016: 2992017: 112018: 42019: 172020: 42021: 52022: 12023: 1
2007high 299 (2016) · low 0 (2007)2025

MAUDE reports naming product code PAG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091—00
20100—00
20110—00
20120—00
20130—084
20140—0256
20150—073
20160—0299
20170—011
20180—04
20190—017
20200—04
20210—05
20220—01
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Brennen Medical, Inc.

17 FDA decisions under this applicant name. See the company

  • K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006
  • K030460Modification to Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 2003
  • K021835Brennen Medical Surgical Mesh, Glucamesh/GlucatexBrennen Medical, Inc. · 2002
  • K002077Glucanpro CreamBrennen Medical, Inc. · 2000
  • K002078Beta Glucan Gel (Macropro Gel)Brennen Medical, Inc. · 2000

Recent decisions in PAG

The PAG category page

  • K090688Cook Urological GraftCook Biotech, Inc. · 2009
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 20051 recall
  • K042949Pelvilace Transobturator Biourethral Support System (Pelvilace to System)C.R. Bard, Inc. · 2004
  • K031295Bard Innerlace Biourethral Support SystemC.R. Bard, Inc. · 2003
  • K030460Modification to Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 2003

https://510kreport.com/device/K982403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982403: Brennen Biosynthetic Surgical Mesh Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982403

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026