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Endologix LLC: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance and 1 PMA approval

Name: Endologix LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Endologix LLC is registered with the FDA (registration 3011063223) in Irvine, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated February 9, 2012. 8 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011063223
Address: 35 Hammond, Irvine, CA, United States, 92618
Owner or operator: Endologix LLC (9034802)
Roles: Manufacturer
First device listed: December 6, 2007
Registered through: 2026
Brand names listed: AFX Delivery System, AFX Introducer System, AFX2 Endovascular Stent Graft System, Powerlink System

Devices it lists

Device	Product code	Class	Role	Source
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm Treatment	MIH	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 9, 2012	K120212	AFX INTRODUCER SYSTEM	DYB	Substantially Equivalent	Endologix, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
October 29, 2004	P040002	ENDOLOGIX POWERLINK SYSTEM	MIH	70	September 27, 2024	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 31, 2018	80812	Class I	Terminated	ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40, BA22-80/I16-40, BA2	Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.	accessdata.fda.gov
January 4, 2017	76256	Class II	Terminated	AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C6	Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.	accessdata.fda.gov
December 27, 2016	76113	Class II	Terminated	AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intend	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).	accessdata.fda.gov
December 27, 2016	76112	Class II	Terminated	AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).	accessdata.fda.gov
December 27, 2016	76110	Class II	Terminated	AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).	accessdata.fda.gov
December 27, 2016	76106	Class II	Terminated	AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).	accessdata.fda.gov
December 27, 2016	76086	Class II	Terminated	AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intende	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).	accessdata.fda.gov
December 27, 2016	76075	Class II	Terminated	AFX Endovascular AAA System, Endoleak Type IIIA	Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).	accessdata.fda.gov

Compare with other makers

Updated September 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.