510(k) Report

510(k) · Cleared

Cleared

Surgisis, Surgisis ES

K062696510(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. · FTM Mesh, Surgical

Cleared on Oct 13, 2006 after a 32-day review. The FDA summary names no predicate by number. 8 later devices descend from it.

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

8 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2013: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK062696 Surgisis, Surgisis ESCook Biotech, Inc. · 2006
  2. Descendant · cites it directly · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
  5. Descendant · 4 generations on · 1 of its ownK192616 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2019
  6. Descendant · 5 generations on · 0 of its ownK201313 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011: 12013: 22014: 12017: 12018: 12019: 12020: 1
2011high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all
  • K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · cites it directly4descendants
  • K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 2 generations on3descendants
  • K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 3 generations on2descendants
  • K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2019 · 4 generations on1descendant
  • K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2020 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062696Surgisis, Surgisis ESCook Biotech, Inc.2006—
+1K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.20142
+2K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope…Aziyo Biologics, Inc.20171
+3K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo…Aziyo Biologics, Inc.20181
+4K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope…Aziyo Biologics, Inc.2019—
+5K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope…Aziyo Biologics, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201410
201710
201810
201910
202010
FIG. 1 — Lineage of K062696, 2006–2020Source: 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?

The FDA summary names no predicate by number.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.20144
K130326Tephaflex Meltblown ConstructTepha, Inc.20130
K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130
K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110

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, K140306 (Cormatrix Cardiovascular, Inc., 2014) has gone furthest, with 4 descendants of its own.

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. 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 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/K062696 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062696: Surgisis, Surgisis ES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062696

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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