510(k) · Cleared
ClearedSurgisis Biodesign Enterocutaneous Fistula Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · FTM Mesh, Surgical
Cleared on Feb 27, 2009 as substantially equivalent to K050337 (Cook Biotech, Inc., 2005) after a 165-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Feb 27, 2009
- Review
- 165 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921895 (1992). 11 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 1 generation backK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
- This deviceK082682 Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK150668 Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated · 2015
Most influential descendants
Showing 1 of 1 · See all- K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −1 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | — |
| 0 (this device) | K082682 | Surgisis Biodesign Enterocutaneous Fistula Plug | Cook Biotech, Inc. | 2009 | — |
| +1 | K150668 | Biodesign Enterocutaneous Fistula Plug | Cook Biotech Incorprated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050337 | Sis Fistula PlugSummary page 1…21 CFR 878.3300 (FTM) Class II Predicate Device: The predicate device is the original SIS Fistula Plug (510(k) No. K050337), cleared for marketing by the Food and Drug Administration on March 9, 2005. Device Description: The modified SIS Fistula Plug… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150668 | Biodesign Enterocutaneous Fistula Plug | 2015 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K150668 (Cook Biotech Incorprated, 2015) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K050337.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082682: Surgisis Biodesign Enterocutaneous Fistula Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082682
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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