Entellus Medical, Inc
United Statesfrom the FDA registration address FDA establishment FEI 3006345872
- Devices
- 27
- Registrations
- FDA
- FDA recalls
- 0
What Entellus Medical, Inc makes
Entellus Medical, Inc. manufactures sinus dilation tools, including the Xpress Multi-Sinus Dilation Tool and the XprESS ENT Dilation System, designed for sinus surgery. Their portfolio also includes LED light fibers and light seekers, such as the PathAssist Light Seeker and PathAssist Light Fiber, used for illumination during procedures. Additionally, they produce sinus guidewires like the Entellus Medical Sinus Guidewire and fine-endoscopic tools such as the Finess Endoscope.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in sinus and nasal cavity procedures, adhering to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 27 devicesCompany details
- FDA FEI number
- 3006345872
- Address
- 3600 Holly Lane North, Suite 40, Plymouth, MN, 55447
Frequently asked questions
How many devices does Entellus Medical, Inc have in the registry?
The registry currently lists 27 devices for Entellus Medical, Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entellus Medical, Inc's devices?
Among its 27 most recently registered devices, Entellus Medical, Inc has devices listed in FDA 510(k) (27 devices).
What risk classes do Entellus Medical, Inc's devices fall under?
Among its 27 most recently registered devices, the classes recorded for Entellus Medical, Inc's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entellus Medical, Inc in the registry?
The most recently registered devices listed for Entellus Medical, Inc include PATHASSIST LIGHT SEEKER, PassAssist LED Light Fiber, XPRESS MULTI-SINUS DILATION TOOL and PATHASSIST LIGHT FIBER.