510(k) · Cleared
ClearedPtfe Ringed Gore-Tex Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Cleared on Sep 8, 1999 after a 114-day review. The FDA summary names its predicate without a number. 103 later devices descend from it.
- Decided
- Sep 8, 1999
- Review
- 114 days
- Class
- Class II
- Product code
- DYF
- Recalls
- None
- Predicates
- 0
103 later devices descend from it, 2 citing it directly.
- This deviceK991683 Ptfe Ringed Gore-Tex Vascular GraftW. L. Gore & Associates, Inc. · 1999
- Descendant · cites it directly · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- Descendant · cites it directly · 77 of its ownK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
- Descendant · 2 generations on · 69 of its ownK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- Descendant · 2 generations on · 48 of its ownK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- Descendant · 3 generations on · 45 of its ownK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · cites it directly102descendants
- K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004 · cites it directly77descendants
- K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations · 2004 · 2 generations on69descendants
- K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP · 2008 · 2 generations on48descendants
- K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010 · 3 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991683 | Ptfe Ringed Gore-Tex Vascular Graft | W. L. Gore & Associates, Inc. | 1999 | — |
| +1 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| +1 | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2004 | — |
| +2 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| +2 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| +3 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 11 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2026 | 4 | 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 DYF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | GORE-TEX Vascular Grafts Named without a submission number | |
| * | — | IMPRA Flex PTFE Vascular Grafts Named without a submission number | |
| * | — | Atrium Hybrid PTFE Vascular Grafts Named without a submission number |
What descends from it? (103)
See all 1032 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K032865 (W. L. Gore & Associates, Inc., 2003) has gone furthest, with 102 descendants of its own.
How does its category compare?
All DYF devicesDYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYF
FDA has decided no DYF device since 2007.
Median 510(k) review, days · DYF
Too few DYF 510(k)s in any year since 2007 to give a median.
Recalls per year · DYF
No recall names DYF since 2007.
Adverse event reports per year · DYF
3in 2025
MAUDE reports naming product code DYF, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ePTFE Ringed GORE-TEX® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991683: Ptfe Ringed Gore-Tex Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991683
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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