510(k) Report

510(k) · Cleared

Cleared

Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft

K062697510(k) SpecialCleared Oct 13, 200632-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. · FTL Mesh, Surgical, Polymeric

Cleared on Oct 13, 2006 after a 32-day review. The FDA summary names no predicate by number. 31 later devices descend from it.

Decided
Oct 13, 2006
Review
32 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

31 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2013: 3 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2014: 5 descendants cleared2010: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2016: 3 descendants cleared2018: 4 descendants cleared2017: 2 descendants cleared2025: 3 descendants cleared2019: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK062697 Sis Hernia Repair Device, Surgisis Gold Hernia Repair GraftCook Biotech, Inc. · 2006
  2. Descendant · cites it directly · 10 of its ownK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
  3. Descendant · cites it directly · 8 of its ownK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008
  4. Descendant · 2 generations on · 6 of its ownK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
  5. Descendant · 3 generations on · 5 of its ownK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
  6. Descendant · cites it directly · 5 of its ownK130547 Endoform Reconstructive TemplateMesynthe, Ltd. · 2013

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 12012: 12013: 32014: 52015: 22016: 32017: 22018: 42019: 22020: 12022: 12024: 12025: 3
2008high 5 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 31 · See all
  • K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010 · cites it directly10descendants
  • K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008 · cites it directly8descendants
  • K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013 · 2 generations on6descendants
  • K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017 · 3 generations on5descendants
  • K130547Endoform Reconstructive TemplateMesynthe, Ltd. · 2013 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062697Sis Hernia Repair Device, Surgisis Gold Hernia Repair GraftCook Biotech, Inc.2006—
+1K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation2010—
+1K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.2008—
+2K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical2013—
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.2017—
+1K130547Endoform Reconstructive TemplateMesynthe, Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201110
201210
201330
201450
201520
201630
201720
201840
201920
202010
202210
202410
202530
FIG. 1 — Lineage of K062697, 2006–2025Source: 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 FTL? 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 FTL device

  1. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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?

The FDA summary names no predicate by number.

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010
K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088
K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135
K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.20144
K133011Diaphragmatic Hernia GraftCook Biotech, Inc.20141
K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150
K133306Sis Hernia GraftCook Biotech, Inc.20140
K111695Hybrid GraftCook Biotech, Inc.20120

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?

  • Of its descendants, K094061 (Kensey Nash Corporation, 2010) has gone furthest, with 10 descendants of its own.

How does its category compare?

All FTL devices

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

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.

Indications for use as stated in the FDA summary.

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 FTL

The FTL category page

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  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K062697 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062697

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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