FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NuVent EM Sinus Dilation System
K Number: K152121
·
Decision Dec 1, 2015
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
37
Review Days
124
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Basic Information
- Device Name
- NuVent EM Sinus Dilation System
- K Number
- K152121
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Xomed, Inc.
- Date Received
- July 30, 2015
- Decision Date
- December 1, 2015
- Product Code
- LRC
- 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 |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Medtronic Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K210841 | NuVent Eustachian Tube Dilation Balloon | Aug 16, 2021 | Substantially Equivalent |
| K200759 | NIM Vital, Nerve Integrity Monitor | Oct 28, 2020 | Substantially Equivalent |
| K173855 | Sharpsite AC Rigid Endsocope | Apr 20, 2018 | 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 |