FDA 510(k) Applications Submitted by ENTELLUS MEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K091681 |
06/10/2009 |
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) |
Entellus Medical, Inc. |
| K120735 |
03/09/2012 |
PATHASSIT LIGHT SEEKER |
Entellus Medical, Inc. |
| K120962 |
03/30/2012 |
PATHASSIST LIGHT FIBER |
Entellus Medical, Inc. |
| K141916 |
07/15/2014 |
PATHASSIST LED LIGHT FIBER |
Entellus Medical, Inc. |
| K133563 |
11/20/2013 |
PATHASSIST LIGHT SEEKER |
Entellus Medical, Inc. |
| K113522 |
11/29/2011 |
PATHASSIST LIGHT SEEKER |
Entellus Medical, Inc. |
| K102003 |
07/15/2010 |
XPRESS BALLOON DEVICE |
Entellus Medical, Inc. |
| K110158 |
01/19/2011 |
ILLUMINATING SINUS SEEKER |
Entellus Medical, Inc. |
| K130503 |
02/27/2013 |
PATHASSIST LED LIGHT FIBER |
Entellus Medical, Inc. |
| K110739 |
03/17/2011 |
ENTELLUS MEDICAL SINUS GUIDEWIRE |
Entellus Medical, Inc. |
| K121174 |
04/17/2012 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K111763 |
06/23/2011 |
PATHASSIST LIGHT FIBER |
Entellus Medical, Inc. |
| K121943 |
07/03/2012 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K132440 |
08/06/2013 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K102366 |
08/20/2010 |
FINESS ENDOSCOPE |
Entellus Medical, Inc. |
| K112506 |
08/30/2011 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
| K103213 |
11/01/2010 |
FINESS ENDOSCOPE STERILIZATION TRAY |
Entellus Medical, Inc. |
| K142252 |
08/14/2014 |
XprESS Multi-Sinus Dilation Tool |
ENTELLUS MEDICAL, INC. |
| K152434 |
08/27/2015 |
XprESS Multi-Sinus Dilation System |
ENTELLUS MEDICAL, INC. |
| K152435 |
08/27/2015 |
PassAssist LED Light Fiber |
ENTELLUS MEDICAL, INC. |
| K163509 |
12/15/2016 |
XprESS ENT Dilation System |
Entellus Medical, Inc. |
| K220027 |
01/05/2022 |
Audion ET dilation system |
Entellus Medical, Inc. |
| K081542 |
06/02/2008 |
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM |
Entellus Medical, Inc. |
| K082569 |
09/05/2008 |
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE |
Entellus Medical, Inc. |
| K093007 |
09/28/2009 |
ENTELLUS MEDICAL BALLOON DEVICE |
Entellus Medical, Inc. |
| K072302 |
08/17/2007 |
ENTELLUS MEDICAL RS-SERIES SYSTEM |
Entellus Medical, Inc. |
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