Medical Device Manufacturer · US , Maple Grove , MN

Entellus Medical, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 2008
27
Total
27
Cleared
0
Denied

FDA 510(k) cleared devices by Entellus Medical, Inc. Ear, Nose, Throat

25 devices
1-25 of 25
Cleared Apr 12, 2022
Audion ET dilation system
K220027 · PNZ
Ear, Nose, Throat · 97d
Cleared Apr 05, 2017
XprESS ENT Dilation System
K163509 · PNZ
Ear, Nose, Throat · 111d
Cleared Nov 20, 2015
XprESS Multi-Sinus Dilation System
K152434 · LRC
Ear, Nose, Throat · 85d
Cleared Nov 20, 2015
PassAssist LED Light Fiber
K152435 · LRC
Ear, Nose, Throat · 85d
Cleared Oct 17, 2014
XprESS Multi-Sinus Dilation Tool
K142252 · LRC
Ear, Nose, Throat · 64d
Cleared Aug 07, 2014
PATHASSIST LED LIGHT FIBER
K141916 · LRC
Ear, Nose, Throat · 23d
Cleared Dec 20, 2013
PATHASSIST LIGHT SEEKER
K133563 · LRC
Ear, Nose, Throat · 30d
Cleared Oct 04, 2013
XPRESS MULTI-SINUS DILATION TOOL
K132440 · LRC
Ear, Nose, Throat · 59d
Cleared Jun 11, 2013
PATHASSIST LED LIGHT FIBER
K130503 · LRC
Ear, Nose, Throat · 104d
Cleared Aug 22, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121943 · LRC
Ear, Nose, Throat · 50d
Cleared May 17, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121174 · LRC
Ear, Nose, Throat · 30d
Cleared Apr 27, 2012
PATHASSIST LIGHT FIBER
K120962 · LRC
Ear, Nose, Throat · 28d
Cleared Apr 02, 2012
PATHASSIT LIGHT SEEKER
K120735 · LRC
Ear, Nose, Throat · 24d
Cleared Jan 27, 2012
PATHASSIST LIGHT SEEKER
K113522 · LRC
Ear, Nose, Throat · 59d
Cleared Dec 21, 2011
XPRESS MULTI-SINUS DILATION TOOL
K112506 · LRC
Ear, Nose, Throat · 113d
Cleared Sep 15, 2011
PATHASSIST LIGHT FIBER
K111763 · LRC
Ear, Nose, Throat · 84d
Cleared Jun 14, 2011
ENTELLUS MEDICAL SINUS GUIDEWIRE
K110739 · LRC
Ear, Nose, Throat · 89d
Cleared Jun 07, 2011
ILLUMINATING SINUS SEEKER
K110158 · LRC
Ear, Nose, Throat · 139d
Cleared Feb 15, 2011
FINESS ENDOSCOPE
K102366 · EOB
Ear, Nose, Throat · 179d
Cleared Oct 22, 2010
XPRESS BALLOON DEVICE
K102003 · LRC
Ear, Nose, Throat · 99d
Cleared Feb 05, 2010
ENTELLUS MEDICAL BALLOON DEVICE
K093007 · LRC
Ear, Nose, Throat · 130d
Cleared Jul 08, 2009
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K091681 · LRC
Ear, Nose, Throat · 28d
Cleared Sep 18, 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · EOB
Ear, Nose, Throat · 13d
Cleared Jun 27, 2008
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
K081542 · LRC
Ear, Nose, Throat · 25d
Cleared Apr 08, 2008
ENTELLUS MEDICAL RS-SERIES SYSTEM
K072302 · LRC
Ear, Nose, Throat · 235d
Filters