# K013282: Gore Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 14, 2001 after 73 days
- Product code: DBY (Fab, Rhodamine, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 1 cites it directly.
2 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FAST-CATH™ Hemostasis Introducer: named in the summary without a submission number

## 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
- K212392: Intri24 Sheath (2022), 5 descendants of its own

## Indications for use
The GORE®Introducer Sheath is used to facilitate the introduction of guidewires, catheters and other interventional medical devices into the vasculature, and to minimize blood loss associated with such introduction.

Source page: https://510kreport.com/device/K013282
Methodology: https://510kreport.com/methodology