# K110090: Afx Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Endologix, Inc.
- Decided: May 26, 2011 after 134 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). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082356: Gore Introducer Sheath with Silicone Pinch Valve, W. L. Gore & Associates, Inc. (2008) Summary page 2.
- K032073: Gore Introducer Sheath with Silicone Pinch Valve, W. L. Gore & Associates, Inc. (2003) Summary page 2.
- K902469: Byrd Dilator Sheath Set - Teflon, Medical Engineering and Development Institute (1990) Summary page 2.
- P040002: Endologix Powerlink System, Endologix, LLC (2004) Summary page 2.

## Most influential descendants
- K111747: Endologix Afx Introducer System (2011), 6 descendants of its own
- K120212: Afx Introducer System (2012), 5 descendants of its own
- K141275: Endophys Pressure Sensing Sheath Kit (2015), 4 descendants of its own
- K160272: Endophys Pressure Sensing Sheath Kit (2016), 3 descendants of its own
- K173399: Endophys Pressure Sensing Sheath Kit- 8F (2017), 1 descendant of its own

## Indications for use
The AFX Introducer System facilitates the introduction of guidewires, catheters, and other medical devices into the vasculature and minimizes blood loss associated with such introduction.

Source page: https://510kreport.com/device/K110090
Methodology: https://510kreport.com/methodology