510(k) · Cleared
ClearedGore Seamguard Bioabsorbable Staple Line Reinforcement Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Dec 22, 2004 as substantially equivalent to K030782 (W. L. Gore & Associates, Inc., 2003) and 2 other predicates after a 47-day review. Its family tree reaches back 7 generations to 1985. 77 later devices descend from it.
- Decided
- Dec 22, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K842066 (1985). 21 ancestors in all. 77 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 4 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 3 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 2 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- This deviceK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
- Descendant · cites it directly · 48 of its ownK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- Descendant · 2 generations on · 45 of its ownK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- Descendant · 2 generations on · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- Descendant · cites it directly · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- Descendant · 2 generations on · 15 of its ownK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP · 2008 · cites it directly48descendants
- K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · 2 generations on45descendants
- K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · 2 generations on44descendants
- K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · cites it directly18descendants
- K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −6 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −4 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −3 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −2 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| 0 (this device) | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2004 | — |
| +1 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| +2 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| +2 | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA… | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 73 |
| +1 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
| +2 | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2026 | 3 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement MaterialSummary page 2…and labeling. * SEAMGUARD®' Bioabsorbable Staple Line Reinforcement Material (WL Gore & Associates, Inc., Flagstaff, AZ) - K030782 and K032865 * GORE-TEX® Vascular Graft (WL Gore & Associates, Flagstaff, AZ) - K991… | 2003 |
| * | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialSummary page 2…g. * SEAMGUARD®' Bioabsorbable Staple Line Reinforcement Material (WL Gore & Associates, Inc., Flagstaff, AZ) - K030782 and K032865 * GORE-TEX® Vascular Graft (WL Gore & Associates, Flagstaff, AZ) - K991683 Summar… | 2003 |
| * | K991683 | Ptfe Ringed Gore-Tex Vascular GraftSummary page 2…& Associates, Inc., Flagstaff, AZ) - K030782 and K032865 * GORE-TEX® Vascular Graft (WL Gore & Associates, Flagstaff, AZ) - K991683 Summary of Studies In vivo studies support the modification to the "Indication for Use" of the GORE… | 1999 |
What descends from it? (77)
See all 777 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line… | 2008 | 48 |
| K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove… | 2010 | 18 |
| K130997 | Neoveil | 2013 | 3 |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | 2018 | 1 |
| K131658 | Gore Seamguard Reinforcement | 2013 | 1 |
| K053200 | Gore Seamguard Staple Line Reinforcement Material | 2005 | 1 |
| K053202 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | 2005 | 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 19 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K080898 (Tyco Healthcare Group LP, 2008) has gone furthest, with 48 descendants of its own.
- 2 other devices also cite its predicate K030782.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery…
Read the full statement (96 words)
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures.
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is also intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043056
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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