510(k) Report

510(k) · Cleared

Cleared

Cook Urological Graft

K090688510(k) TraditionalCleared Jul 10, 2009116-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

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

Cleared on Jul 10, 2009 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 2 other predicates after a 116-day review. Its family tree reaches back 4 generations to 1992.

Decided
Jul 10, 2009
Review
116 days
Class
Class II
Product code
PAG
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K921895 (1992). 11 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1983: 1 other ancestor1992: 1 other ancestorK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 1998K992159 · Surgisis Sling · Cook Biotech, Inc. · 19991980198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 1 other ancestor K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 19920
  1. Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 1 generation backK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. This deviceK090688 Cook Urological GraftCook Biotech, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−3K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−2K980431SurgisisCook Biotech, Inc.1998—
−1K992159Surgisis SlingCook Biotech, Inc.1999—
0 (this device)K090688Cook Urological GraftCook Biotech, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199620
199710
199810
200510
FIG. 1 — Lineage of K090688, 1992–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K980431Surgisis
Summary page 1
…for one-time use. DEVICE DESCRIPTION: The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGISIS® Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by…
Cook Biotech, Inc.1998—
*K992159Surgisis Sling
Summary page 1
…CRIPTION: The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGISIS® Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufa…
Cook Biotech, Inc.1999—
*K051701Vicryl * Mesh Bag
Summary page 1
…atrix that is identical to the predicates SURGISIS® Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine smail intestinal submucosa (SIS), packaged in a lyophilized (d…
ETHICON, Inc.2005—

Also cleared against K980431: 28 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • None of the 11 ancestors has a recall.
  • 28 other devices also cite its predicate K980431.

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. 2009, this device’s year, is highlighted.

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 COOK Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The device is supplied sterile and intended for one-time use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K980431

28 other devices cite the same predicate.

  • K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftCook Biotech Incorporated · 2019
  • K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016
  • K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated · 20161 recall
  • K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 20142 recalls
  • K134033Miromatrix Biological MeshMiromatrix Medical, Inc. · 2014
  • K130547Endoform Reconstructive TemplateMesynthe, Ltd. · 2013

More from Cook Biotech, Inc.

31 FDA decisions under this applicant name. See the company

  • K133306Sis Hernia GraftCook Biotech, Inc. · 2014
  • K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 20141 recall
  • K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc. · 2013
  • K111695Hybrid GraftCook Biotech, Inc. · 2012
  • K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc. · 2011

Recent decisions in PAG

The PAG category page

  • 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
  • K020654Stratasis Sling KitCook Biotech, Inc. · 2002

https://510kreport.com/device/K090688 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090688: Cook Urological Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090688

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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