510(k) Report

510(k) · Cleared

Cleared

Sis Wound Dressing

K973170510(k) TraditionalCleared Apr 30, 1998248-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Biotech, Inc. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Apr 30, 1998 after a 248-day review. The FDA summary names no predicate by number. 237 later devices descend from it.

Decided
Apr 30, 1998
Review
248 days
Class
Class U
Product code
KGN
Recalls
None
Predicates
0

237 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2000: 2 descendants cleared1998: 1 descendant cleared2006: 8 descendants cleared2002: 7 descendants cleared2003: 4 descendants cleared2008: 11 descendants cleared2005: 3 descendants cleared2009: 13 descendants cleared2004: 4 descendants cleared2010: 12 descendants cleared2015: 7 descendants cleared2007: 11 descendants cleared2014: 10 descendants cleared2013: 8 descendants cleared2025: 15 descendants cleared2020: 3 descendants cleared2012: 12 descendants cleared2022: 11 descendants cleared2021: 8 descendants cleared2017: 16 descendants cleared2018: 9 descendants cleared2023: 8 descendants cleared2026: 13 descendants cleared2016: 9 descendants cleared2011: 12 descendants cleared2019: 6 descendants cleared2024: 14 descendants cleared1995200020052010201520202025
  1. This deviceK973170 Sis Wound DressingCook Biotech, Inc. · 1998
  2. Descendant · cites it directly · 235 of its ownK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
  3. Descendant · cites it directly · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  4. Descendant · 2 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  5. Descendant · cites it directly · 92 of its ownK982330 Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998
  6. Descendant · 2 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003

Showing 5 of 237 descendants. See all descendants

Descendants cleared per year

1998: 12000: 22002: 72003: 42004: 42005: 32006: 82007: 112008: 112009: 132010: 122011: 122012: 122013: 82014: 102015: 72016: 92017: 162018: 92019: 62020: 32021: 82022: 112023: 82024: 142025: 152026: 13
1998high 16 (2017) · low 0 (1999)2026

Most influential descendants

Showing 5 of 237 · See all
  • K993948Sis Wound Dressing IICook Biotech, Inc. · 2000 · cites it directly235descendants
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · cites it directly173descendants
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 2 generations on102descendants
  • K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998 · cites it directly92descendants
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 2 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973170Sis Wound DressingCook Biotech, Inc.1998—
+1K993948Sis Wound Dressing IICook Biotech, Inc.2000—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+1K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.1998—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200020
200270
200340
200440
200530
200680
2007110
2008110
2009130
2010120
2011120
2012120
201380
2014100
201570
201690
2017160
201890
201960
202030
202180
2022110
202380
2024140
2025150
2026130
FIG. 1 — Lineage of K973170, 1998–2026Source: 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 KGN? 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 KGN device

  1. #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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? (237)

See all 237

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

NumberDeviceApplicantDecidedDescendants
K993948Sis Wound Dressing IICook Biotech, Inc.2000235
K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173
K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892

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, K993948 (Cook Biotech, Inc., 2000) has gone furthest, with 235 descendants of its own.

How does its category compare?

All KGN devices

KGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGN

15so far in 2026, the most since 2007

2007: 32008: 62009: 82010: 42011: 72012: 82013: 62014: 52015: 72016: 42017: 72018: 62019: 32020: 52021: 62022: 122023: 92024: 132025: 102026 (partial year): 15
2007high 15 (2026) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGN

162in 2025

2007: 32 days median2008: 87 days median2009: 121 days median2010: 175 days median2011: 228 days median2012: 123 days median2013: 147 days median2014: 188 days median2015: 87 days median2016: 164 days median2017: 136 days median2018: 148 days median2019: 128 days median2020: 279 days median2021: 236 days median2022: 246 days median2023: 194 days median2024: 83 days median2025: 162 days median2026 (partial year): 174 days median
2007high 279 (2020) · low 32 (2007)2026

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

Recalls per year · KGN

3in 2018

2017: 12018: 3
2007high 3 (2018) · low 0 (2007)2026

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

Adverse event reports per year · KGN

15in 2025

2008: 12009: 22010: 32011: 62012: 42013: 62014: 122015: 92016: 62017: 82018: 152019: 112020: 172021: 142022: 132023: 212024: 152025: 15
2007high 21 (2023) · low 0 (2007)2025

MAUDE reports naming product code KGN, 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
200733200
200868701
2009812102
2010417503
2011722806
2012812304
2013614706
20145188012
201578709
2016416406
2017713618
20186148315
20193128011
20205279017
20216236014
202212246013
20239194021
20241383015
202510162015
2026151740—

What is it indicated for?

The SIS Wound Dressing is intended for temporary coverage of partial-thickness skin loss injury, such as burns, abrasions, decubitus and chronic vascular ulcers, and autograft donor sites. 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.

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 KGN

The KGN category page

  • K260920Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc…Berkeley Advanced Biomaterials · 2026
  • K260530epi-ConneKt™ Wound MatrixMLM Biologics, Inc. · 2026
  • K260652ColActive PlusCovalon Technologies, Ltd. · 2026
  • K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus…Berkeley Advanced Biomaterials · 2026
  • K260596Collagen Wound PowderVentris Medical · 2026

https://510kreport.com/device/K973170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973170: Sis Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973170

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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