# K082356: Gore Introducer Sheath with Silicone Pinch Valve

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Aug 28, 2008 after 10 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032073 (2003). 1 ancestor in all.
41 later devices descend from it; 2 cite it directly.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032073: Gore Introducer Sheath with Silicone Pinch Valve, W. L. Gore & Associates, Inc. (2003) Summary page 1.

## Most influential descendants
- K093791: Gore Dryseal Sheath (2010), 32 descendants of its own
- K121234: Gore (R) Dryseal Sheath with Hydrophilic Coating (2012), 18 descendants of its own
- K160254: GORE DrySeal Flex Introducer Sheath (2016), 9 descendants of its own
- K123990: Sentrant Introducer Sheath with Hydrophilic Coating (2013), 7 descendants of its own
- K110090: Afx Introducer System (2011), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K082356
Methodology: https://510kreport.com/methodology