# K160254: GORE DrySeal Flex Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 12, 2016 after 101 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K032073 (2003). 5 ancestors in all.
9 later devices descend from it; 6 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121234: Gore (R) Dryseal Sheath with Hydrophilic Coating, W. L. Gore & Associates, Inc. (2012) Summary page 4.
- K093791: Gore Dryseal Sheath, W. L. Gore & Associates, Inc. (2010) Summary page 4.

## Most influential descendants
- K222113: Abiomed 14Fr Low Profile Introducer Set (2022), 2 descendants of its own
- K241708: Abiomed 14Fr Low Profile Introducer Kit (2024), 1 descendant of its own
- K171206: D'Vill Introducer (2017), 1 descendant of its own
- K260606: Echo Large Bore Introducer Sheath (2026), 0 descendants of its own
- K260091: Aventus Introducer Sheath (2026), 0 descendants of its own

## Recalls of this device
- Nov 18, 2019 · Class II · Z-1962-2020: The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.

## Indications for use
The GORE® DrySeal Flex Introducer 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/K160254
Methodology: https://510kreport.com/methodology