Data / Medical devices / United States / Endologix LLC

Endologix LLC: FDA-registered device maker in Santa Rosa, CA, United States, 4 510(k) clearances and 3 PMA approvals

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 3008011247) in Santa Rosa, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances and 3 PMA approvals under its listings, the newest dated September 11, 2024. 4 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008011247
Address: 3910 Brickway Blvd, Santa Rosa, CA, United States, 95403
Owner or operator: Endologix LLC (9034802)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: December 6, 2007
Registered through: 2026
Brand names listed: AFX Delivery System, AFX Introducer System, AFX2 Endovascular Stent Graft System, Alto Abdominal Stent Graft System, Detour System, Ovation Abdominal Stent Graft System, Ovation Prime Abdominal Stent Graft System, Ovation Stent Graft System and more

Devices it lists

Device	Product code	Class	Role	Source
Introducer, Catheter	DYB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stent Graft, Bypass, Superficial Femoral Artery	QWM	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm Treatment	MIH	3	Complaint file establishment, Manufacturer, Specification developer	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
September 11, 2024	K241362	Pounce XL Thrombectomy System (PTS-1011-7F135)	QEW	Substantially Equivalent	Surmodics,Inc.	accessdata.fda.gov
June 12, 2023	K231022	Pounce Thrombectomy System	QEW	Substantially Equivalent	Surmodics,Inc.	accessdata.fda.gov
March 23, 2022	K220501	Pounce Thrombectomy System	QEW	Substantially Equivalent	Surmodics,Inc.	accessdata.fda.gov
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
June 7, 2023	P220021	DETOUR System	QWM	9	October 16, 2026	accessdata.fda.gov
October 5, 2012	P120006	OVATION ABDOMINAL STENT GRAFT SYSTEM	MIH	38	June 3, 2026	accessdata.fda.gov
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
May 6, 2020	85480	Class I	Terminated	Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J	A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.	accessdata.fda.gov
September 20, 2014	69326	Class I	Terminated	Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdom	TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.	accessdata.fda.gov
February 27, 2014	67672	Class II	Terminated	Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a sm	Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.	accessdata.fda.gov
October 19, 2012	63586	Class II	Terminated	TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft S	Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon	accessdata.fda.gov

Compare with other makers

Updated October 16, 2026. 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.