Entellus Medical, Inc

Matched from indexed company URL: Entellus Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3006345872	3006345872	Entellus Medical, Inc	1	N	2026-01-01	3600 Holly Lane North, Suite 40 Plymouth MN US 55447

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
224756	1665168098	K981751	SINUSCOPE AND ACCESSORIES	EOB	1998-08-13
224756	1797350066	K193502	TGS Universal Headrest with Mounting Arm	PGW	2020-02-14
224756	1700583036	K193118	TGS Guidewire and updated Scopis Software	PGW	2020-02-21
224756	1368656052	K192661	LATERA Absorbable Nasal Implant System	NHB	2019-11-10
224756	1861662661	K163509	XprESS ENT Dilation System	PNZ	2017-04-05
224756	1619868673	K163435	Entellus Medical Reinforced Anesthesia Needle	BSP	2017-04-05
224756	2008017237	K161191	Latera Absorbable Nasal Implant	NHB	2016-06-23
224756	1615959581	K152958	INEX Absorbable Nasal Implant	NHB	2015-12-04
224756	1067997162	K152435	PassAssist LED Light Fiber	LRC	2015-11-20
224756	1987072691	K152434	XprESS Multi-Sinus Dilation System	LRC	2015-11-20
224756	1719758922	K142252	XprESS Multi-Sinus Dilation Tool	LRC	2014-10-17
224756	1274419742	K133563	PATHASSIST LIGHT SEEKER	LRC	2013-12-20
224756	1569315793	K113585	NASAL/EPISTAXIS PACK	LYA	2012-04-25
224756	1361005219
224756	1646301590
224756	1017176448
224756	1038371666
224756	1203444525
224756	1223036166
224756	1678962605
224756	1993276853

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NHB	4	2019-11-10
LRC	4	2015-11-20
PGW	2	2020-02-21
PNZ	1	2017-04-05
BSP	1	2017-04-05
LYA	1	2012-04-25
EOB	1	1998-08-13

PMN#

Audion ET dilation system

2022-04-12

Entellus Medical, Inc.

LATERA Absorbable Nasal Implant System

2019-11-10

Entellus Medical, Inc. (Aka Stryker ENT)

Entellus Medical Reinforced Anesthesia Needle

2017-04-05

Entellus Medical Inc.

XprESS ENT Dilation System

2017-04-05

Entellus Medical, Inc.

XprESS Multi-Sinus Dilation System

2015-11-20

ENTELLUS MEDICAL, INC.

PassAssist LED Light Fiber

2015-11-20

ENTELLUS MEDICAL, INC.

XprESS Multi-Sinus Dilation Tool

2014-10-17

ENTELLUS MEDICAL, INC.

PATHASSIST LED LIGHT FIBER

2014-08-07

Entellus Medical, Inc.

PATHASSIST LIGHT SEEKER

2013-12-20

Entellus Medical, Inc.

XPRESS MULTI-SINUS DILATION TOOL

2013-10-04

Entellus Medical, Inc.

PATHASSIST LED LIGHT FIBER

2013-06-11

Entellus Medical, Inc.

XPRESS MULTI-SINUS DILATION TOOL

2012-08-22

Entellus Medical, Inc.

XPRESS MULTI-SINUS DILATION TOOL

2012-05-17

Entellus Medical, Inc.

PATHASSIST LIGHT FIBER

2012-04-27

Entellus Medical, Inc.

PATHASSIT LIGHT SEEKER

2012-04-02

Entellus Medical, Inc.

PATHASSIST LIGHT SEEKER

2012-01-27

Entellus Medical, Inc.

XPRESS MULTI-SINUS DILATION TOOL

2011-12-21

Entellus Medical, Inc.

PATHASSIST LIGHT FIBER

2011-09-15

Entellus Medical, Inc.

ENTELLUS MEDICAL SINUS GUIDEWIRE

2011-06-14

Entellus Medical, Inc.

ILLUMINATING SINUS SEEKER

2011-06-07

Entellus Medical, Inc.

FINESS ENDOSCOPE

2011-02-15

Entellus Medical, Inc.

FINESS ENDOSCOPE STERILIZATION TRAY

2011-02-02

Entellus Medical, Inc.

XPRESS BALLOON DEVICE

2010-10-22

Entellus Medical, Inc.

ENTELLUS MEDICAL BALLOON DEVICE

2010-02-05

Entellus Medical, Inc.

FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)

2009-07-08

Entellus Medical, Inc.

ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE

2008-09-18

Entellus Medical, Inc.

MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM

2008-06-27

Entellus Medical, Inc.

ENTELLUS MEDICAL RS-SERIES SYSTEM

2008-04-08

Entellus Medical, Inc.

GUDID#

XeroGel - Nasal Epistaxis 8 Pack

ENTELLUS MEDICAL, INC.

2020-09-10

XeroGel - Nasal Epistaxis 2 Pack

ENTELLUS MEDICAL, INC.

2020-09-10

Shaver Blade 2.1mm Single Use Double Serrated Straight - The Shaver 2.1mm Single Use Double Serrated Straight Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 4mm Single Use Double Serrated 60° - The Shaver 4mm Single Use Double Serrated 60° Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 4mm Single Use Double Serrated 40° - The Shaver 4mm Single Use Double Serrated 40° Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 4mm Single Use Double Serrated Straight - The Shaver 4mm Single Use Double Serrated Straight Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 3mm Single Use Double Serrated 60° - The Shaver 3mm Single Use Double Serrated 60° Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 3mm Single Use Double Serrated 40° - The Shaver 3mm Single Use Double Serrated 40° Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 3mm Single Use Double Serrated Straight - The Shaver 3mm Single Use Double Serrated Straight Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 4mm Reusable Double Serrated Straight - The Shaver 4mm Reusable Double Serrated Straight Blade is used with the Shaver System. The blade is a reusable device supplied sterile and requires reprocessing (cleaning, lubrication and sterilization) after the initial use. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 3mm Reusable Double Serrated Straight - The Shaver 3mm Reusable Double Serrated Straight Blade is used with the Shaver System. The blade is a reusable device supplied sterile and requires reprocessing (cleaning, lubrication and sterilization) after the initial use. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Shaver Blade 2.1mm Reusable Double Serrated Straight - The Shaver 2.1mm Reusable Double Serrated Straight Blade is used with the Shaver System. The blade is a reusable device supplied sterile and requires reprocessing (cleaning, lubrication and sterilization) after the initial use. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

2020-09-25

Entellus Medical Reinforced Anesthesia Needle - The Reinforced Anesthesia Needle is a disposable medical device that allows the user to transnasally administer anesthetic solutions. The needle may be reshaped along the 3.5” length.

ENTELLUS MEDICAL, INC.

2017-05-18

Entellus Medical Reinforced Anesthesia Needle - The Reinforced Anesthesia Needle is a disposable medical device that allows the user to transnasally administer anesthetic solutions. The needle may be reshaped along the 3.5” length.

ENTELLUS MEDICAL, INC.

2017-05-18

LATERA - nasal implant delivery device

ENTELLUS MEDICAL, INC.

2017-09-19

LATERA - absorbable nasal implant

ENTELLUS MEDICAL, INC.

2016-07-21

LATERA - nasal implant delivery device

ENTELLUS MEDICAL, INC.

2016-07-21