Medical Device Manufacturer · US , Maple Grove , MN

Entellus Medical, Inc.

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

Entellus Medical, Inc. — FDA 510(k) Submissions

Entellus Medical, Inc. has submitted 27 FDA 510(k) premarket notifications since 2008, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Instrument, Ent Manual Surgical, Nasopharyngoscope (flexible Or Rigid), Eustachian Tube Balloon Dilation Device, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Needle, Conduction, Anesthetic (w/wo Introducer) . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
Audion ET dilation system
K220027 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
Apr 2022 97d
Entellus Medical Reinforced Anesthesia Needle
K163435 · BSP Needle, Conduction,... · Anesthesiology
Apr 2017 119d
XprESS ENT Dilation System
K163509 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
Apr 2017 111d
XprESS Multi-Sinus Dilation System
K152434 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Nov 2015 85d
PassAssist LED Light Fiber
K152435 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Nov 2015 85d
XprESS Multi-Sinus Dilation Tool
K142252 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Oct 2014 64d
PATHASSIST LED LIGHT FIBER
K141916 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Aug 2014 23d
PATHASSIST LIGHT SEEKER
K133563 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Dec 2013 30d
XPRESS MULTI-SINUS DILATION TOOL
K132440 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Oct 2013 59d
PATHASSIST LED LIGHT FIBER
K130503 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Jun 2013 104d
XPRESS MULTI-SINUS DILATION TOOL
K121943 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Aug 2012 50d
XPRESS MULTI-SINUS DILATION TOOL
K121174 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
May 2012 30d
PATHASSIST LIGHT FIBER
K120962 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Apr 2012 28d
PATHASSIT LIGHT SEEKER
K120735 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Apr 2012 24d
PATHASSIST LIGHT SEEKER
K113522 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Jan 2012 59d
XPRESS MULTI-SINUS DILATION TOOL
K112506 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Dec 2011 113d
PATHASSIST LIGHT FIBER
K111763 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Sep 2011 84d
ENTELLUS MEDICAL SINUS GUIDEWIRE
K110739 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Jun 2011 89d
ILLUMINATING SINUS SEEKER
K110158 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Jun 2011 139d
FINESS ENDOSCOPE
K102366 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Feb 2011 179d
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · KCT Sterilization Wrap... · General Hospital
Feb 2011 93d
XPRESS BALLOON DEVICE
K102003 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Oct 2010 99d
ENTELLUS MEDICAL BALLOON DEVICE
K093007 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Feb 2010 130d
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K091681 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Jul 2009 28d
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Sep 2008 13d
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