Company ยท US
Entellus Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2022. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2022 | K220027 | Audion ET dilation system Entellus Medical, Inc. | PNZ |
| Apr 5, 2017 | K163509 | XprESS ENT Dilation System Entellus Medical, Inc. | PNZ |
| Apr 5, 2017 | K163435 | Entellus Medical Reinforced Anesthesia Needle Entellus Medical, Inc. | BSP |
| Nov 20, 2015 | K152435 | PassAssist LED Light Fiber Entellus Medical, Inc. | LRC |
| Nov 20, 2015 | K152434 | XprESS Multi-Sinus Dilation System Entellus Medical, Inc. | LRC |
| Oct 17, 2014 | K142252 | XprESS Multi-Sinus Dilation Tool Entellus Medical, Inc. | LRC |
| Aug 7, 2014 | K141916 | PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. | LRC |
| Dec 20, 2013 | K133563 | PATHASSIST LIGHT SEEKER Entellus Medical, Inc. | LRC |
| Oct 4, 2013 | K132440 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| Jun 11, 2013 | K130503 | PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. | LRC |
| Aug 22, 2012 | K121943 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| May 17, 2012 | K121174 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| Apr 27, 2012 | K120962 | PATHASSIST LIGHT FIBER Entellus Medical, Inc. | LRC |
| Apr 2, 2012 | K120735 | PATHASSIT LIGHT SEEKER Entellus Medical, Inc. | LRC |
| Jan 27, 2012 | K113522 | PATHASSIST LIGHT SEEKER Entellus Medical, Inc. | LRC |
| Dec 21, 2011 | K112506 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| Sep 15, 2011 | K111763 | PATHASSIST LIGHT FIBER Entellus Medical, Inc. | LRC |
| Jun 14, 2011 | K110739 | ENTELLUS MEDICAL SINUS GUIDEWIRE Entellus Medical, Inc. | LRC |
| Jun 7, 2011 | K110158 | ILLUMINATING SINUS SEEKER Entellus Medical, Inc. | LRC |
| Feb 15, 2011 | K102366 | FINESS ENDOSCOPE Entellus Medical, Inc. | EOB |
| Feb 2, 2011 | K103213 | FINESS ENDOSCOPE STERILIZATION TRAY Entellus Medical, Inc. | KCT |
| Oct 22, 2010 | K102003 | XPRESS BALLOON DEVICE Entellus Medical, Inc. | LRC |
| Feb 5, 2010 | K093007 | ENTELLUS MEDICAL BALLOON DEVICE Entellus Medical, Inc. | LRC |
| Jul 8, 2009 | K091681 | FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) Entellus Medical, Inc. | LRC |
| Sep 18, 2008 | K082569 | ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE Entellus Medical, Inc. | EOB |
| Jun 27, 2008 | K081542 | MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. | LRC |
| Apr 8, 2008 | K072302 | ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. | LRC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||