FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
K Number: K213246
·
Decision Mar 21, 2022
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
37
Review Days
172
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Basic Information
- Device Name
- NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
- K Number
- K213246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Xomed, Inc.
- Date Received
- September 30, 2021
- Decision Date
- March 21, 2022
- Product Code
- ETN
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETN), ordered by most recent decision date.
Evala Nerve Stimulator (EPNR002)
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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 |
| 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 |
| 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 |