FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Acclarent Aera Eustachian Tube Balloon Dilation System
K Number: DEN150056
·
Decision Sep 16, 2016
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
45
Review Days
284
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Basic Information
- Device Name
- Acclarent Aera Eustachian Tube Balloon Dilation System
- K Number
- DEN150056
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 874.4180
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Unknown
- Applicant
- Acclarent, Inc.
- Date Received
- December 7, 2015
- Decision Date
- September 16, 2016
- 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 Acclarent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Feb 19, 2026 | Substantially Equivalent |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Dec 13, 2023 | Substantially Equivalent |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Jul 21, 2023 | Substantially Equivalent |
| K221037 | TruDi Shaver Blade | Jul 20, 2022 | Substantially Equivalent |
| K201115 | Next Generation Balloon Dilation System | Aug 27, 2020 | Substantially Equivalent |
| K201174 | TruDi Curette | Aug 12, 2020 | Substantially Equivalent |
| K193453 | TruDi Probe | Mar 23, 2020 | Substantially Equivalent |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | May 3, 2019 | Substantially Equivalent |
| K190532 | TruDi NAV Wire | May 3, 2019 | Substantially Equivalent |
| K183090 | Relieva Tract Balloon Dilation System | Apr 19, 2019 | Substantially Equivalent |