510(k) Report

510(k) · Cleared

Cleared

Surgisis Peyronie's Repair Graft, Model SPR-100

K062320510(k) TraditionalCleared Oct 2, 200654-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 Oct 2, 2006 as substantially equivalent to K992159 (Cook Biotech, Inc., 1999) and 2 other predicates after a 54-day review. Its family tree reaches back 10 generations to 1993. 1 later device descends from it.

Decided
Oct 2, 2006
Review
54 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
3

Its longest line of descent runs back 10 generations to K931386 (1993). 38 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1998: 3 other ancestors2004: 3 other ancestors2002: 5 other ancestors1997: 1 other ancestor1996: 4 other ancestors1983: 1 other ancestor2003: 1 other ancestor2001: 3 other ancestors2000: 2 other ancestors1992: 3 other ancestors2016: 1 descendant clearedK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK972651 · IN-Sling · Influence, Inc. · 1997K980482 · Triangle Sling · Influence, Inc. · 1998×2: 2 generations cleared close together, K002721 (2000), K010931 (2001) ×3: 3 generations cleared close together, K033636 (2003), K040521 (2004), K040623 (2004) K050445 · Ams Collagen Dermal Matrix · American Medical Systems, Inc. · 2005 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 11 other ancestors4 generations back: 3 other ancestors6 generations back: 2 other ancestors 1 generation forward: 1 descendant K050445 · Ams Collagen Dermal Matrix · American Medical Systems, Inc. · 2005 · recalledK040623 · Ams Perigee System · American Medical Systems, Inc. · 2004K040521 · Modification to Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2004K033636 · Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2003K010931 · Ams Sacral Colpopexy Sling, Model 72403501 · American Medical Systems, Inc. · 2001K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K980482 · Triangle Sling · Influence, Inc. · 1998K972651 · IN-Sling · Influence, Inc. · 1997K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993−10−50
  1. Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 6 generations between
  3. 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  4. 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  5. 1 generation backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
  6. This deviceK062320 Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc. · 2006
  7. Descendant · cites it directly · 0 of its ownK160869 Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's…Cook Biotech Incorporated · 2016 · Recalled
Show all 10 generations
  1. Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. 5 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
  7. 4 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  8. 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  9. 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  10. 1 generation backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
  11. This deviceK062320 Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−9K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−8K972651IN-SlingInfluence, Inc.1997—
−7K980482Triangle SlingInfluence, Inc.1998—
−6K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
−5K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.2001—
−4K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
−3K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
−2K040623Ams Perigee SystemAmerican Medical Systems, Inc.2004—
−1K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.20051
0 (this device)K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.2006—
+1K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated20161

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199230
199640
199710
199830
199920
200020
200130
200250
200310
200430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K062320, 1993–2016Source: 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? (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
…me use only. Predicate Devices: The SURGISIS® Peyronie's Repair Graft is similar in terms of substantial equivalence to the following predicate devices: SURGISIS® Sling (K992159) and SURGIS/45 Mesh (K980431) devices, both manufactured by Cook Biotech Incorporated, and AMS Collagen Dermal Matrix (K050445) m…
Cook Biotech, Inc.1999—
*K980431Surgisis
Summary page 1
…s: The SURGISIS® Peyronie's Repair Graft is similar in terms of substantial equivalence to the following predicate devices: SURGISIS® Sling (K992159) and SURGIS/45 Mesh (K980431) devices, both manufactured by Cook Biotech Incorporated, and AMS Collagen Dermal Matrix (K050445) manufactured by American Medic…
Cook Biotech, Inc.1998—
*K050445Ams Collagen Dermal Matrix
Summary page 1
…lowing predicate devices: SURGISIS® Sling (K992159) and SURGIS/45 Mesh (K980431) devices, both manufactured by Cook Biotech Incorporated, and AMS Collagen Dermal Matrix (K050445) manufactured by American Medical Systems. Device Description: The SURGISIS® Peyronie's Repair Graft is manufactured from porcine…
American Medical Systems, Inc.20051

Also cleared against K992159: 12 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated20160

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 5 companies; a new generation was cleared every 1.1 years on median.
  • 4 of the 38 ancestors have a recall of any class.
  • Of its descendants, K160869 (Cook Biotech Incorporated, 2016) has gone furthest, with 0 descendants of its own.
  • 12 other devices also cite its predicate K992159.

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 SURGISIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. The device is supplied sterile and is intended for one-time use.

Indications for use as stated in the FDA summary.

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
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 20051 recall

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/K062320 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062320: Surgisis Peyronie's Repair Graft, Model SPR-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062320

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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