510(k) Report

510(k) · Cleared

Cleared

Biodesign Nipple Reconstruction Cylinder

K110402510(k) TraditionalCleared Jun 20, 2011129-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 Jun 20, 2011 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 4 other predicates after a 129-day review. Its family tree reaches back 5 generations to 1992.

Decided
Jun 20, 2011
Review
129 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K921895 (1992). 18 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2002: 1 other ancestor2000: 4 other ancestors1997: 3 other ancestors1983: 1 other ancestor2001: 1 other ancestor1992: 1 other ancestorK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 1998K034039 · Sis Plastic Surgery Matrix · Cook Biotech, Inc. · 2004K050246 · Sis Dermal Augmentation Strand · Cook Biotech, Inc. · 20051980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 7 other ancestors K050246 · Sis Dermal Augmentation Strand · Cook Biotech, Inc. · 2005K034039 · Sis Plastic Surgery Matrix · Cook Biotech, Inc. · 2004K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992−50
  1. Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 2 generations backK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
  5. 1 generation backK050246 Sis Dermal Augmentation StrandCook Biotech, Inc. · 2005
  6. This deviceK110402 Biodesign Nipple Reconstruction CylinderCook Biotech, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−4K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−3K980431SurgisisCook Biotech, Inc.1998—
−2K034039Sis Plastic Surgery MatrixCook Biotech, Inc.2004—
−1K050246Sis Dermal Augmentation StrandCook Biotech, Inc.2005—
0 (this device)K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199730
200040
200110
200210
200610
200710
FIG. 1 — Lineage of K110402, 1992–2011Source: 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? (5)

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
*K980431Surgisis
Summary page 1
…Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The S15 material is identical to the predicates SurgiSIS® Mesh (K98043 1, K062696), 515 Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incor…
Cook Biotech, Inc.1998—
*K062696Surgisis, Surgisis ES
Summary page 1
…s composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The S15 material is identical to the predicates SurgiSIS® Mesh (K98043 1, K062696), 515 Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated.…
Cook Biotech, Inc.2006—
*K034039Sis Plastic Surgery Matrix
Summary page 1
…llular collagen matrix (Small Intestinal Submucosa, SIS). The S15 material is identical to the predicates SurgiSIS® Mesh (K98043 1, K062696), 515 Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cy…
Cook Biotech, Inc.2004—
*K050246Sis Dermal Augmentation Strand
Summary page 1
…stinal Submucosa, SIS). The S15 material is identical to the predicates SurgiSIS® Mesh (K98043 1, K062696), 515 Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and av…
Cook Biotech, Inc.2005—
*K070738Sis Facial Cylinder, Sis Facial Implant
Summary page 1
…bmucosa, SIS). The S15 material is identical to the predicates SurgiSIS® Mesh (K98043 1, K062696), 515 Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available i…
Cook Biotech, Inc.2007—

Also cleared against K980431: 28 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • None of the 18 ancestors has a recall.
  • 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. 2011, this device’s year, is highlighted.

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 Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce

soft tissue in plastic and reconstructive surgery of the nipple. The cylinder 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
  • K090688Cook Urological GraftCook Biotech, Inc. · 2009

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/K110402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110402: Biodesign Nipple Reconstruction Cylinder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110402

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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