| Device Type ID | 1461 |
| Device Name | Stimulator, Nerve |
| Regulation Description | Surgical Nerve Stimulator/locator. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.1820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ETN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1461 |
| Device | Stimulator, Nerve |
| Product Code | ETN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Nerve Stimulator/locator. |
| CFR Regulation Number | 874.1820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AD-TECH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AD-TECH MEDICAL INSTRUMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INOMED MEDIZINTECHNIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NDI MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPES MEDICA S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 104 |
Use Of Device Problem | 84 |
Failure To Sense | 53 |
False Negative Result | 42 |
Device Sensing Problem | 38 |
Adverse Event Without Identified Device Or Use Problem | 35 |
Unable To Obtain Readings | 29 |
Air Leak | 26 |
Noise, Audible | 21 |
Sensing Intermittently | 20 |
Device Stops Intermittently | 15 |
Occlusion Within Device | 14 |
Material Puncture / Hole | 12 |
Partial Blockage | 11 |
Leak / Splash | 10 |
Break | 9 |
Inflation Problem | 7 |
Deflation Problem | 6 |
Intermittent Continuity | 6 |
Electrical /Electronic Property Problem | 5 |
Connection Problem | 5 |
False Positive Result | 5 |
Failure To Read Input Signal | 5 |
Difficult To Remove | 4 |
Loose Or Intermittent Connection | 4 |
Fitting Problem | 3 |
Material Deformation | 3 |
Failure To Deliver Energy | 3 |
Material Fragmentation | 3 |
Device Inoperable | 3 |
Device Displays Incorrect Message | 3 |
Obstruction Of Flow | 3 |
Deformation Due To Compressive Stress | 2 |
Signal Artifact | 2 |
No Display / Image | 2 |
No Flow | 2 |
Self-Activation Or Keying | 2 |
Invalid Sensing | 2 |
Failure To Fire | 2 |
Fracture | 2 |
Gas Leak | 2 |
Decrease In Pressure | 2 |
Electrical Shorting | 2 |
Detachment Of Device Component | 2 |
Audible Prompt / Feedback | 2 |
Mechanical Problem | 2 |
No Device Output | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Insufficient Information | 1 |
Failure To Discharge | 1 |
Device Alarm System | 1 |
Thermal Decomposition Of Device | 1 |
Computer Software Problem | 1 |
Failure To Analyze Signal | 1 |
Material Rupture | 1 |
No Audible Prompt / Feedback | 1 |
Device Damaged Prior To Use | 1 |
Low Battery | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
Complete Loss Of Power | 1 |
Peeled / Delaminated | 1 |
Device-Device Incompatibility | 1 |
Material Too Rigid Or Stiff | 1 |
Device Issue | 1 |
Material Protrusion / Extrusion | 1 |
Complete Blockage | 1 |
Use Of Incorrect Control Settings | 1 |
Defective Component | 1 |
Missing Information | 1 |
Increase In Pressure | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
Degraded | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
| Total Device Problems | 649 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Xomed, Inc. | II | Dec-23-2016 |
| 2 | Spine Wave, Inc. | II | Jul-02-2015 |