FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XprESS ENT Dilation System
K Number: K163509
·
Decision Apr 5, 2017
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
27
Review Days
111
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- XprESS ENT Dilation System
- K Number
- K163509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4180
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Entellus Medical, Inc.
- Date Received
- December 15, 2016
- Decision Date
- April 5, 2017
- Product Code
- PNZ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNZ | Eustachian Tube Balloon Dilation Device | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNZ), ordered by most recent decision date.
Acclarent AERA Eustachian Tube Balloon Dilation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ACCLARENT AERA Eustachian Tube Dilation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TubaVent Balloon Dilatation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Audion ET dilation system
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NuVent Eustachian Tube Dilation Balloon
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Entellus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220027 | Audion ET dilation system | Apr 12, 2022 | Substantially Equivalent |
| K163435 | Entellus Medical Reinforced Anesthesia Needle | Apr 5, 2017 | Substantially Equivalent |
| K152435 | PassAssist LED Light Fiber | Nov 20, 2015 | Substantially Equivalent |
| K152434 | XprESS Multi-Sinus Dilation System | Nov 20, 2015 | Substantially Equivalent |
| K142252 | XprESS Multi-Sinus Dilation Tool | Oct 17, 2014 | Substantially Equivalent |
| K141916 | PATHASSIST LED LIGHT FIBER | Aug 7, 2014 | Substantially Equivalent |
| K133563 | PATHASSIST LIGHT SEEKER | Dec 20, 2013 | Substantially Equivalent |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Oct 4, 2013 | Substantially Equivalent |
| K130503 | PATHASSIST LED LIGHT FIBER | Jun 11, 2013 | Substantially Equivalent |
| K121943 | XPRESS MULTI-SINUS DILATION TOOL | Aug 22, 2012 | Substantially Equivalent |