FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
K Number: K230065
·
Decision May 26, 2023
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
16
Review Days
137
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Basic Information
- Device Name
- VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
- K Number
- K230065
- 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
- Fiagon GmbH
- Date Received
- January 9, 2023
- Decision Date
- May 26, 2023
- 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
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
ACCLARENT AERA Eustachian Tube Balloon Dilation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Fiagon GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye Pro | Jun 2, 2026 | Substantially Equivalent |
| K230700 | RIWOtrack Navigation System | Nov 20, 2023 | Substantially Equivalent |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Jul 19, 2021 | Substantially Equivalent |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Aug 26, 2020 | Substantially Equivalent |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Mar 10, 2020 | Substantially Equivalent |
| K163209 | Fiagon Navigation System | Sep 14, 2017 | Substantially Equivalent |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | Feb 16, 2017 | Substantially Equivalent |
| K162176 | Fiagon Navigation System | Dec 1, 2016 | Substantially Equivalent |
| K161940 | Guidewire 0.6 Single Use | Sep 18, 2016 | Substantially Equivalent |
| K151156 | Fiagon Navigation System | Apr 1, 2016 | Substantially Equivalent |