FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NuVent Eustachian Tube Dilation Balloon
K Number: K210841
·
Decision Aug 16, 2021
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
37
Review Days
147
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Basic Information
- Device Name
- NuVent Eustachian Tube Dilation Balloon
- K Number
- K210841
- 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
- Medtronic Xomed, Inc.
- Date Received
- March 22, 2021
- Decision Date
- August 16, 2021
- 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
ACCLARENT AERA Eustachian Tube Balloon Dilation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Medtronic Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Feb 10, 2026 | Substantially Equivalent |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Oct 26, 2023 | Substantially Equivalent |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Aug 30, 2023 | Substantially Equivalent |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Mar 21, 2022 | Substantially Equivalent |
| K200759 | NIM Vital, Nerve Integrity Monitor | Oct 28, 2020 | Substantially Equivalent |
| K173855 | Sharpsite AC Rigid Endsocope | Apr 20, 2018 | Substantially Equivalent |
| K152121 | NuVent EM Sinus Dilation System | Dec 1, 2015 | Substantially Equivalent |
| K151758 | ALAR Nasal Valve Stent | Oct 29, 2015 | Substantially Equivalent |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Aug 14, 2015 | Substantially Equivalent |
| K151067 | Ventilation (Tympanostomy) Tubes | Jul 22, 2015 | Substantially Equivalent |