Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006345872

FEI Number

3006345872

Entity Name

Entellus Medical, Inc

City/State/Country

Plymouth, MN, US

Establishment Address

3600 Holly Lane North, Suite 40, Plymouth, MN 55447, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sickle Knife Blakesley Forceps 45 Degree Blakesley Forceps Straight Turbinate Forceps Blakesley Forceps 90 Degree Blakesley Forcep Thru-Cut Straight Forceps Takahashi Blakesley Forcep Thru-Cut 45 Degree Maxillary Seeker Sphenoid Seeker/Freer add name FoCESS HD Wireless Camera System TGS Field Generator Stand XeroGel Nasal/Epistaxis Pack Portable Red LED Light Source Office Sinus Procedure Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-12-28
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1977-12-30
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	1997-07-03
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2018-12-28
QLV	Field Generator Positioning Device	Neurology	Class 1	882.4565	2021-12-22
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2018-12-28
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2018-12-28
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2018-12-28
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Similar Registrations

Registration Number	Establishment Name	Location
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE
3002692886	MANI, INC. (HEAD OFFICE)	UTSUNOMIYA Tochigi, JP
3010726901	EVONOS GMBH & CO. KG	Tuttlingen Baden-Wurttemberg, DE
3001084743	Bailey Instruments Ltd	Manchester, GB
1057946	KLS-Martin L.P.	Jacksonville, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006345872. Last updated year: 2026. Please use registration number 3006345872 when referencing this establishment in official correspondence.