510(k) · Cleared
ClearedGore Introducer Sheath with Silicone Pinch Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · DYB Introducer, Catheter
Cleared on Aug 28, 2008 as substantially equivalent to K032073 (W. L. Gore & Associates, Inc., 2003) after a 10-day review. Its family tree reaches back 1 generation to 2003. 3 of the 43 devices in its family, counting itself, have a Class I recall. 41 later devices descend from it.
- Decided
- Aug 28, 2008
- Review
- 10 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032073 (2003). 41 later devices descend from it, 2 citing it directly. 3 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- This deviceK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- Descendant · cites it directly · 32 of its ownK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- Descendant · 2 generations on · 18 of its ownK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK160254 GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 7 of its ownK123990 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013
- Descendant · cites it directly · 7 of its ownK110090 Afx Introducer SystemEndologix, Inc. · 2011
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 41 · See all- K093791Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010 · cites it directly32descendants
- K121234Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012 · 2 generations on18descendants
- K160254GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · 2 generations on9descendants
- K123990Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013 · 2 generations on7descendants
- K110090Afx Introducer SystemEndologix, Inc. · 2011 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| 0 (this device) | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| +1 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| +2 | K121234 | Gore (R) Dryseal Sheath with Hydrophilic Coating | W. L. Gore & Associates, Inc. | 2012 | — |
| +2 | K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2016 | 1 |
| +2 | K123990 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular | 2013 | — |
| +1 | K110090 | Afx Introducer System | Endologix, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 1 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 1 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 1 |
| 2025 | 5 | 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.
3 devices in this family have a Class I recall. 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K032073 | Gore Introducer Sheath with Silicone Pinch ValveSummary page 1…Device Name: GORE Introducer Sheath with Silicone Pinch Valve Common Name: Introducer Sheath Classification: 21lCFR 870.1340, DYB Class LI Device Predicate: K032073 GORE Introducer Sheath with Silicone Pinch Valve Device Description: This 5 10(k) is being submitted for a minor modification t… | 2003 |
What descends from it? (41)
See all 412 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K120212Afx Introducer SystemEndologix, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The GORE Introducer Sheath with Silicone Pinch Valve is indicated for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082356 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082356: Gore Introducer Sheath with Silicone Pinch Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082356
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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