510(k) Report

510(k) · Cleared

Cleared

Stratasis Sling Kit

K020654510(k) TraditionalCleared Apr 9, 200240-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 Apr 9, 2002 as substantially equivalent to K992159 (Cook Biotech, Inc., 1999) and 2 other predicates after a 40-day review. Its family tree reaches back 4 generations to 1992.

Decided
Apr 9, 2002
Review
40 days
Class
Class II
Product code
PAG
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K921895 (1992). 12 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 3 other ancestors1996: 2 other ancestors1997: 1 other ancestor1983: 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. · 199919801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 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 deviceK020654 Stratasis Sling KitCook Biotech, Inc. · 2002
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)K020654Stratasis Sling KitCook Biotech, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199620
199710
199830
FIG. 1 — Lineage of K020654, 1992–2002Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K992159Surgisis Sling
Summary page 1
…ic sphincter deficiency. Predicate Devices: The STRATASIS™ Sling Kit is similar in terms of substantial equivalence to the following predicate devices: SURGISIS Sling (K992159) manufactured by Cook Biotech Incorporated; the SIS Hernia Repair Device (K974540) manufactured by Cook Biotech Incorporated, and…
Cook Biotech, Inc.1999—
*K974540Sis Hernia Repair Device
Summary page 1
…n terms of substantial equivalence to the following predicate devices: SURGISIS Sling (K992159) manufactured by Cook Biotech Incorporated; the SIS Hernia Repair Device (K974540) manufactured by Cook Biotech Incorporated, and Tension Free Vaginal Tape (K974098) marketed by GYNECARE. Device Description: Th…
Sentron Medical, Inc.1998—
*K974098Pubouurethral Sling
Summary page 1
…ing (K992159) manufactured by Cook Biotech Incorporated; the SIS Hernia Repair Device (K974540) manufactured by Cook Biotech Incorporated, and Tension Free Vaginal Tape (K974098) marketed by GYNECARE. Device Description: The STRATASIS™ Sling Kit is composed of a strip of SIS material with TEVDEK® suture…
ETHICON, Inc.1998—

Also cleared against K992159: 12 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 10 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • None of the 12 ancestors has a recall.
  • 12 other devices also cite its predicate K992159.

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 STRATASIS™ Sling Kit is a sterile, single-use device intended to be used as a pubourethral sting indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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 K992159

12 other devices cite the same predicate.

  • K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated · 2016
  • K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated · 2013
  • K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
  • K090688Cook Urological GraftCook Biotech, Inc. · 2009
  • K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008
  • K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc. · 2006

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/K020654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020654: Stratasis Sling Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020654

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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