510(k) Report

510(k) · Cleared

Cleared

Surgisis Sling

K992159510(k) TraditionalCleared Sep 23, 199990-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 Sep 23, 1999 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1992. 204 later devices descend from it.

Decided
Sep 23, 1999
Review
90 days
Class
Class II
Product code
PAG
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K921895 (1992). 9 ancestors in all, the oldest K830889 (1983). 204 later devices descend from it, 13 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 2 other ancestors1997: 1 other ancestor1983: 1 other ancestor1992: 1 other ancestor2005: 6 descendants cleared2000: 1 descendant cleared2002: 6 descendants cleared2004: 3 descendants cleared2009: 14 descendants cleared2016: 10 descendants cleared2008: 13 descendants cleared2006: 9 descendants cleared2010: 9 descendants cleared2013: 7 descendants cleared2003: 3 descendants cleared2015: 6 descendants cleared2019: 6 descendants cleared2017: 13 descendants cleared2011: 10 descendants cleared2007: 9 descendants cleared2018: 8 descendants cleared2012: 9 descendants cleared2014: 6 descendants cleared2025: 13 descendants cleared2024: 12 descendants cleared2021: 6 descendants cleared2023: 6 descendants cleared2026: 10 descendants cleared2022: 7 descendants cleared2020: 2 descendants clearedK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 199819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 13 descendants2 generations forward: 24 descendants3 generations forward: 42 descendants4 generations forward: 55 descendants5 generations forward: 34 descendants6 generations forward: 29 descendants7 generations forward: 4 descendants8 generations forward: 3 descendants K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 19920+5
  1. Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
  4. This deviceK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. Descendant · cites it directly · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  6. Descendant · 2 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  7. Descendant · 2 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
  8. Descendant · 3 generations on · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004
  9. Descendant · 2 generations on · 51 of its ownK021056 PermacolTissue Science Laboratories, Plc · 2002

Showing 5 of 204 descendants. See all descendants

Descendants cleared per year

2000: 12002: 62003: 32004: 32005: 62006: 92007: 92008: 132009: 142010: 92011: 102012: 92013: 72014: 62015: 62016: 102017: 132018: 82019: 62020: 22021: 62022: 72023: 62024: 122025: 132026: 10
2000high 14 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 204 · See all
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · cites it directly173descendants
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 2 generations on102descendants
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 2 generations on91descendants
  • K042809CuffpatchOrganogenesis, Inc. · 2004 · 3 generations on72descendants
  • K021056PermacolTissue Science Laboratories, Plc · 2002 · 2 generations on51descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−2K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−1K980431SurgisisCook Biotech, Inc.1998—
0 (this device)K992159Surgisis SlingCook Biotech, Inc.1999—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—
+3K042809CuffpatchOrganogenesis, Inc.2004—
+2K021056PermacolTissue Science Laboratories, Plc2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199620
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200260
200330
200430
200560
200690
200790
2008130
2009140
201090
2011100
201290
201370
201460
201560
2016100
2017130
201880
201960
202020
202160
202270
202360
2024120
2025130
2026100
FIG. 1 — Lineage of K992159, 1992–2026Source: 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? (4)

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
…sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. PREDICATE DEVICES: Surgisis® Mesh (K98043 1) manufactured by Cook Biotech Incorporated Glycar Staple Strips (K954665) manufactured by Glycar, Incorporated Mentor Suspend™ S…
Cook Biotech, Inc.1998—
*K954665Glycar Staple Strips
Summary page 1
…m urethral hypermobility or intrinsic sphincter deficiency. PREDICATE DEVICES: Surgisis® Mesh (K98043 1) manufactured by Cook Biotech Incorporated Glycar Staple Strips (K954665) manufactured by Glycar, Incorporated Mentor Suspend™ Sling (K980483) manufactured by Mentor Corporation Surgical Fabrics (K9632…
Glycar, Inc.1996—
*K980483Mentor Suspend Sling
Summary page 1
…DEVICES: Surgisis® Mesh (K98043 1) manufactured by Cook Biotech Incorporated Glycar Staple Strips (K954665) manufactured by Glycar, Incorporated Mentor Suspend™ Sling (K980483) manufactured by Mentor Corporation Surgical Fabrics (K963226) manufactured by Boston Scientific DEVICE DESCRIPTION: The Surgis…
Mentor Corp.1998—
*K963226Surgical Fabrics
Summary page 1
…ch Incorporated Glycar Staple Strips (K954665) manufactured by Glycar, Incorporated Mentor Suspend™ Sling (K980483) manufactured by Mentor Corporation Surgical Fabrics (K963226) manufactured by Boston Scientific DEVICE DESCRIPTION: The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 c…
Boston Scientific Corp1996—

Also cleared against K980431: 28 other devices →

What descends from it? (204)

See all 204

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

NumberDeviceApplicantDecidedDescendants
K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173
K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238
K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.200530
K050337Sis Fistula PlugCook Biotech, Inc.200527
K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010
K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166
K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044
K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082
K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061
K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130

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 7 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K001738 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 173 descendants of its own.
  • 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.

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 Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrecolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The device is supplied sterile and is 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

  • 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/K992159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992159: Surgisis Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992159

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