510(k) Report

510(k) · Cleared

Cleared

Sis Fistula Plug

K050337510(k) TraditionalCleared Mar 9, 200527-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. · FTM Mesh, Surgical

Cleared on Mar 9, 2005 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1992. 27 later devices descend from it.

Decided
Mar 9, 2005
Review
27 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K921895 (1992). 10 ancestors in all, the oldest K830889 (1983). 27 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1983: 1 other ancestor1992: 1 other ancestor2019: 1 descendant cleared2009: 2 descendants cleared2016: 3 descendants cleared2008: 1 descendant cleared2006: 1 descendant cleared2017: 4 descendants cleared2015: 1 descendant cleared2014: 1 descendant cleared2021: 1 descendant cleared2018: 1 descendant cleared2024: 2 descendants cleared2025: 3 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared2023: 2 descendants cleared2020: 1 descendant clearedK921895 · 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. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 5 other ancestors3 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants 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+5
  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 deviceK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
  6. Descendant · cites it directly · 12 of its ownK083266 Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009
  7. Descendant · 2 generations on · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
  8. Descendant · cites it directly · 6 of its ownK161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal…Cook Biotech Incorporated · 2016
  9. Descendant · cites it directly · 5 of its ownK170016 Biodesign Fistula PlugCook Biotech Incorporated · 2017
  10. Descendant · cites it directly · 4 of its ownK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 22014: 12015: 12016: 32017: 42018: 12019: 12020: 12021: 12022: 12023: 22024: 22025: 32026: 2
2006high 4 (2017) · low 0 (2007)2026

Most influential descendants

Showing 5 of 27 · See all
  • K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009 · cites it directly12descendants
  • K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · 2 generations on10descendants
  • K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated · 2016 · cites it directly6descendants
  • K170016Biodesign Fistula PlugCook Biotech Incorporated · 2017 · cites it directly5descendants
  • K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated · 2019 · cites it directly4descendants
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)K050337Sis Fistula PlugCook Biotech, Inc.2005—
+1K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.2009—
+2K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.2014—
+1K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated2016—
+1K170016Biodesign Fistula PlugCook Biotech Incorporated2017—
+1K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery…Cook Biotech Incorporated2019—

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
200610
200810
200920
201410
201510
201630
201740
201810
201910
202010
202110
202210
202320
202420
202530
202620
FIG. 1 — Lineage of K050337, 1992–2026Source: 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 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 FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FTM device

  1. #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K980431SurgisisCook Biotech, Inc.1998—
*K992159Surgisis Sling
Summary page 1
…s, including the SURGISIS® by Cook Biotech (K98043 I) and the STRATASIS® Urethral Sling (K992159), both manufactured Incorporated. Device Description:…
Cook Biotech, Inc.1999—

Also cleared against K980431: 28 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912
K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166
K170016Biodesign Fistula PlugCook Biotech Incorporated20175
K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194
K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082
K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091
K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170
K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.20060

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 13 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K083266 (W. L. Gore & Associates, Inc., 2009) has gone furthest, with 12 descendants of its own.
  • 28 other devices also cite its predicate K980431.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTM

1in 2025

2007: 92008: 92009: 72010: 22011: 62012: 42013: 42014: 82015: 42016: 72017: 92018: 22019: 62020: 42021: 42023: 22024: 32025: 12026 (partial year): 1
2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007: 104 days median2008: 86 days median2009: 86 days median2011: 100 days median2012: 66 days median2013: 123 days median2014: 153 days median2015: 316 days median2016: 88 days median2017: 147 days median2019: 107 days median2020: 59 days median2021: 61 days median2024: 29 days median
2007high 316 (2015) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTM

1in 2023

2007: 72008: 12010: 12011: 82018: 212019: 42020: 12021: 12023: 1
2007high 21 (2018) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTM

232in 2025

2007: 602008: 1412009: 4762010: 1972011: 2882012: 4672013: 3,3512014: 1,0932015: 9772016: 5092017: 5292018: 3572019: 4182020: 4572021: 3692022: 3752023: 4852024: 3832025: 232
2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, 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
20079104760
20089861141
20097860476
20102—1197
201161008288
20124660467
2013412303,351
2014815301,093
201543160977
20167880509
201791470529
20182—21357
201961074418
20204591457
20214611369
20220—0375
20232—1485
20243290383
20251—0232
20261—0—

What is it indicated for?

The SIS Fistula Plug is for implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal, and enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.

Indications for use as stated in the FDA summary.

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 FTM

The FTM category page

  • K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
  • K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025
  • K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc. · 2024
  • K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
  • K241126OviTex PRSTELA Bio, Inc. · 2024

https://510kreport.com/device/K050337 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050337: Sis Fistula Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050337

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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