510(k) Report

510(k) · Cleared

Cleared

Surgisis

K980431510(k) TraditionalCleared May 28, 1998113-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 May 28, 1998 as substantially equivalent to K961810 (Bio-Vascular, Inc., 1996) and 2 other predicates after a 113-day review. Its family tree reaches back 2 generations to 1992. 284 later devices descend from it.

Decided
May 28, 1998
Review
113 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K921895 (1992). 5 ancestors in all, the oldest K830889 (1983). 284 later devices descend from it, 29 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1983: 1 other ancestor1992: 1 other ancestor2019: 8 descendants cleared2000: 1 descendant cleared2005: 11 descendants cleared2014: 15 descendants cleared2004: 5 descendants cleared2013: 12 descendants cleared2009: 15 descendants cleared2011: 13 descendants cleared1999: 1 descendant cleared2008: 17 descendants cleared2002: 9 descendants cleared1998: 1 descendant cleared2007: 13 descendants cleared2006: 12 descendants cleared2016: 17 descendants cleared2003: 5 descendants cleared2012: 12 descendants cleared2017: 19 descendants cleared2015: 8 descendants cleared2010: 10 descendants cleared2021: 7 descendants cleared2018: 12 descendants cleared2023: 9 descendants cleared2022: 9 descendants cleared2025: 15 descendants cleared2026: 11 descendants cleared2024: 13 descendants cleared2020: 4 descendants clearedK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 29 descendants2 generations forward: 58 descendants3 generations forward: 64 descendants4 generations forward: 71 descendants5 generations forward: 38 descendants6 generations forward: 23 descendants7 generations forward: 1 descendant K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 19920+5
  1. Root · 2 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 1 generation backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. This deviceK980431 SurgisisCook Biotech, Inc. · 1998
  4. Descendant · cites it directly · 204 of its ownK992159 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 · cites it directly · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
  8. Descendant · cites it directly · 92 of its ownK982330 Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998

Showing 5 of 284 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12000: 12002: 92003: 52004: 52005: 112006: 122007: 132008: 172009: 152010: 102011: 132012: 122013: 122014: 152015: 82016: 172017: 192018: 122019: 82020: 42021: 72022: 92023: 92024: 132025: 152026: 11
1998high 19 (2017) · low 0 (2001)2026

Most influential descendants

Showing 5 of 284 · See all
  • K992159Surgisis SlingCook Biotech, Inc. · 1999 · cites it directly204descendants
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · cites it directly173descendants
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 2 generations on102descendants
  • K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · cites it directly93descendants
  • K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998 · cites it directly92descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−1K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
0 (this device)K980431SurgisisCook Biotech, Inc.1998—
+1K992159Surgisis SlingCook Biotech, Inc.1999—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+1K034039Sis Plastic Surgery MatrixCook Biotech, Inc.2004—
+1K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200010
200290
200350
200450
2005110
2006120
2007130
2008170
2009150
2010100
2011130
2012120
2013120
2014150
201580
2016170
2017190
2018120
201980
202040
202170
202290
202390
2024130
2025150
2026110
FIG. 1 — Lineage of K980431, 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 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? (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
*K961810Supple Peri-Guard Pericardium
Summary page 1
…Common/Usual Name: Surgical Mesh, Soft Tissue Patch Proposed Classification Name: Surgical Mesh (21 CFR §878.3300) Predicate Devices: Supple Peri-Guard® Pericardium (K961810) manufactured by Bio-Vascular, Inc. GraftPatch® Soft Tissue Surgical Patch (K970561) manufactured by Organogenesis, Inc. DEXON Po…
Bio-Vascular, Inc.1996—
*K970561Graft Patch
Summary page 1
…Surgical Mesh (21 CFR §878.3300) Predicate Devices: Supple Peri-Guard® Pericardium (K961810) manufactured by Bio-Vascular, Inc. GraftPatch® Soft Tissue Surgical Patch (K970561) manufactured by Organogenesis, Inc. DEXON Polyglycolic Acid Mesh (K830889) manufactured by Davis & Geck, Inc. Device Descriptio…
Organogenesis, Inc.1997—
*K830889Dexon 'S' Polyglycolic Acid Mesh
Summary page 1
…ricardium (K961810) manufactured by Bio-Vascular, Inc. GraftPatch® Soft Tissue Surgical Patch (K970561) manufactured by Organogenesis, Inc. DEXON Polyglycolic Acid Mesh (K830889) manufactured by Davis & Geck, Inc. Device Description: SurgiS/S™ is supplied in sheet form in sizes ranging from 16 cm? to 360…
Davis & Geck, Inc.1983—

Also cleared against K961810: 4 other devices →

What descends from it? (284)

See all 284

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

NumberDeviceApplicantDecidedDescendants
K992159Surgisis SlingCook Biotech, Inc.1999204
K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173
K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493
K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892
K043366Permacol Surgical ImplantTissue Science Laboratories, Plc200474
K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.200256
K021056PermacolTissue Science Laboratories, Plc200251
K021105Fortaflex Surgical MeshOrganogenesis, Inc.200242
K050337Sis Fistula PlugCook Biotech, Inc.200527
K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515

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 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K992159 (Cook Biotech, Inc., 1999) has gone furthest, with 204 descendants of its own.
  • 4 other devices also cite its predicate K961810.

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?

SurgiSIS™ is intended for implantation to reinforce soft tissue. This device 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 K961810

4 other devices cite the same predicate.

  • K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013
  • K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 19983 recalls
  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips…Bio-Vascular, Inc. · 19982 recalls
  • K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc. · 1997

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/K980431 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980431: Surgisis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980431

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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