510(k) Report

FDA applicant

Endologix, Inc.

Irvine, CA9 decisions1998–202320 recalls

FDA records 9 decisions for Endologix, Inc. (Irvine, CA) from 1998 to 2023: 5 510(k) clearances and 4 original PMA approvals. Most are in product codes DYB (Introducer, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 7 predicates, 4 of them its own earlier devices. 20 recalls are linked to its devices, 3 Class I.

FDA’s records also spell it “Endologix, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Endologix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12011: 22012: 22023: 1
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2012: 12013: 1, 1 Class I2014: 1, 1 Class I2016: 62017: 22020: 1, 1 Class I
2007high 6 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Endologix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Endologix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DYBIntroducer, Catheter3decisions
  • DQYCatheter, Percutaneous2decisions
  • MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment2decisions
  • QWMStent Graft, Bypass, Superficial Femoral Artery1decision
  • LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous1decision

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120212Afx Introducer SystemEndologix, Inc. · 20121cites it
  • K991601Dual Lumen Catheter, Model DL-35-90Endologix, Inc. · 19991cites it
  • K110090Afx Introducer SystemEndologix, Inc. · 20111cites it
  • K111747Endologix Afx Introducer SystemEndologix, Inc. · 20111cites it
  • P040002Endologix Powerlink SystemEndologix, LLC · 20041cites it

What has FDA decided for it lately?

  • P220021DETOUR SystemEndologix, LLC · 2023
  • P120006Ovation Abdominal Stent Graft SystemEndologix, LLC · 20122 Class I recalls
  • K120212Afx Introducer SystemEndologix, Inc. · 20121 Class I recall
  • K111747Endologix Afx Introducer SystemEndologix, Inc. · 2011
  • K110090Afx Introducer SystemEndologix, Inc. · 2011
  • K080360Endologix Visiflex Dual Lumen CatheterEndologix, Inc. · 2008
  • P040002Endologix Powerlink SystemEndologix, LLC · 200416 recalls
  • K991601Dual Lumen Catheter, Model DL-35-90Endologix, Inc. · 1999

All 6 as Endologix, Inc. →All 3 as Endologix, LLC →

What has been recalled?

20 recalls linked to its devices; the latest:

  • P120006Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I…May 6, 2020Class I
  • P040002AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40…Jan 4, 2017Class II
  • P040002AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308…Jan 4, 2017Class II
  • P040002AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is…Dec 27, 2016Class II
  • P040002AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA…Dec 27, 2016Class II
  • P040002AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and…Dec 27, 2016Class II