# K120212: Afx Introducer System

- Pathway: 510(k) (Special)
- Applicant: Endologix, Inc.
- Decided: Feb 9, 2012 after 16 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (1 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). 6 ancestors in all.
5 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)
- K111747: Endologix Afx Introducer System, Endologix, Inc. (2011) Summary page 2.

## Most influential descendants
- 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
- K190098: Endophys Pressure Sensing Sheath (2019), 0 descendants of its own
- K180620: Endophys Pressure Sensing Sheath Kit (2018), 0 descendants of its own

## Recalls of this device
- May 13, 2013 · Class I · Z-1436-2013: Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.

## Indications for use
The Endologix AFX Introducer System is intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

Source page: https://510kreport.com/device/K120212
Methodology: https://510kreport.com/methodology