# K093791: Gore Dryseal Sheath

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Mar 22, 2010 after 102 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: 2 generations back to K032073 (2003). 3 ancestors in all.
32 later devices descend from it; 6 cite it directly.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013282: Gore Introducer Sheath, W. L. Gore & Associates, Inc. (2001) Summary page 2.
- K032073: Gore Introducer Sheath with Silicone Pinch Valve, W. L. Gore & Associates, Inc. (2003) Summary page 3.
- K082356: Gore Introducer Sheath with Silicone Pinch Valve, W. L. Gore & Associates, Inc. (2008) Summary page 3.

## Most influential descendants
- 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
- K212392: Intri24 Sheath (2022), 5 descendants of its own
- K140793: Nanostim Introducer Kit (2014), 3 descendants of its own

## Indications for use
The GORE DrySeal Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Source page: https://510kreport.com/device/K093791
Methodology: https://510kreport.com/methodology