# Endologix, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 9 (1998–2023): 5 510(k) clearances and 4 original PMA approvals
- Names in FDA's records: Endologix, Inc. (6); Endologix, LLC (3)
- Product codes: DYB (3), DQY (2), MIH (2), QWM (1), LOX (1)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 20 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 2 (https://510kreport.com/company/w-l-gore-associates)
- Medical Engineering and Development Institute: 1 (https://510kreport.com/company/medical-engineering-and-development-institute)

## Firms that cite its devices most
- Endophys, Inc.: 1 (https://510kreport.com/company/endophys)

## Its most-cited devices
- K120212: Afx Introducer System (2012), cited by 1
- K991601: Dual Lumen Catheter, Model DL-35-90 (1999), cited by 1
- K110090: Afx Introducer System (2011), cited by 1
- K111747: Endologix Afx Introducer System (2011), cited by 1
- P040002: Endologix Powerlink System (2004), cited by 1

## Recent decisions
- P220021: DETOUR System (Jun 7, 2023)
- P120006: Ovation Abdominal Stent Graft System (Oct 5, 2012)
- K120212: Afx Introducer System (Feb 9, 2012)
- K111747: Endologix Afx Introducer System (Jul 12, 2011)
- K110090: Afx Introducer System (May 26, 2011)
- K080360: Endologix Visiflex Dual Lumen Catheter (Apr 8, 2008)
- P040002: Endologix Powerlink System (Oct 29, 2004)
- K991601: Dual Lumen Catheter, Model DL-35-90 (Oct 28, 1999)

Source page: https://510kreport.com/company/endologix