FDA Registration
Active
🇺🇸 United States
Entellus Medical, Inc
Reg #: 3006345872
·
FEI: 3006345872
·
Expires 2026
Products
13
Proprietary Names
21
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- Entellus Medical, Inc
- Registration Number
- 3006345872
- FEI Number
- 3006345872
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3600 Holly Lane North, Suite 40
- City
- Plymouth
- State
- MN
- ZIP
- 55447
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113585
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2018-12-28 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1977-12-30 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 1997-07-03 |
| Camera, Cine, Endoscopic, Without Audio | FWL | Class 1 | General, Plastic Surgery | No | 2018-12-28 |
| Field Generator Positioning Device | QLV | Class 1 | Neurology | No | 2021-12-22 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2018-12-28 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2018-12-28 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2018-12-28 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2018-12-28 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2023-07-06 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2018-11-29 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2018-11-29 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2020-04-17 |
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
FocESS Sinuscopes
Latera Absorbable Nasal Implant System
Entellus Medical Reinforced Anesthesia Needle
TGS Universal Headrest with Mounting Arm
XprESS Multi-Sinus Dilation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility