Company ยท US
Endologix Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2012. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
26recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 2012 | K120212 | AFX INTRODUCER SYSTEM Endologix, Inc. | DYB |
| Jul 12, 2011 | K111747 | ENDOLOGIX AFX INTRODUCER SYSTEM Endologix, Inc. | DYB |
| May 26, 2011 | K110090 | AFX INTRODUCER SYSTEM Endologix, Inc. | DYB |
| Apr 8, 2008 | K080360 | ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER Endologix, Inc. | DQY |
| Oct 28, 1999 | K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 Endologix, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2020 | Endologix, Inc. 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 Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF:
I16-16/C55,
I16-16/C55F,
I16-16/C88,
I20-13/C70F,
I20-13/C88F,
I16-16/C55 Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO,
AFX Proximal Accessory,
Infrarenal Model #/REF:
A22-22/C55,
A22-22/C75,
A22-22/C95,
A25-25/C55, Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF:
BEA22-120/I20-40,
BEA22-100/I20-40,
BEA22-80/I20-40,
BEA22-60/I20-40,
BEA22-40/I20-4 Terminated |
MIH | None listed |
| Oct 3, 2018 | Endologix 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, Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX2 Endovascular AAA System
Item No. Item Description
F00820-01 BEA28-120/I20-40
F00820-02 BEA28-100/I20-40
F00820-03 BEA28-80/I20-40
F00820-06 BEA28-120/I16-40
F00820-07 BEA28-100/I16-40
F008 Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX Endovascular AAA System
Item Number Item Description
F0070305 A2525/C75 V
F0070308 A2828/C75 V
F0070312 A3434/C80 V
f00553 Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix 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 Endovascula Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix 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). Terminated |
MIH | None listed |
| Jan 19, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type IIIB
Common Name: AFX Bifurcated and Accessory Stent Grafts
Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment Terminated |
MIH | None listed |
| Jan 18, 2017 | Endologix 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). Terminated |
MIH | None listed |
| Jan 18, 2017 | Endologix 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 Terminated |
MIH | None listed |
| Jan 18, 2017 | Endologix AFX Endovascular AAA System, Endoleak Type IIIA Terminated |
MIH | None listed |
| Jun 7, 2013 | Endologix Inc Brand Name: AFX" Introducer System, Model Number S17-45.
Lot Numbers: 1079840, 1079843, 1079844, 1079845.
Product Usage:
The AFX Introducer System is intended for use to facilitate the introduction o Terminated |
DYB | K120212 |
| Jan 11, 2010 | Endologix Inc Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000. Terminated |
OAD | None listed |
| Jan 11, 2010 | Endologix Inc Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998. Terminated |
OAD | None listed |
| Dec 27, 2006 | Endologix Inc Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL Terminated |
MIH | None listed |
| Dec 27, 2006 | Endologix Inc Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL Terminated |
MIH | None listed |
| Mar 22, 2006 | Endologix Inc Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL Terminated |
MIH | None listed |