| Device Type ID | 3659 |
| Device Name | Probe, Radiofrequency Lesion |
| Regulation Description | Radiofrequency Lesion Probe. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3659 |
| Device | Probe, Radiofrequency Lesion |
| Product Code | GXI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radiofrequency Lesion Probe. |
| CFR Regulation Number | 882.4725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIROS TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EPIMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EPIMED INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HALYARD HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LCCS PRODUCTS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIEVANT MEDSYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Break | 82 |
Material Separation | 60 |
Adverse Event Without Identified Device Or Use Problem | 54 |
Material Discolored | 50 |
Contamination / Decontamination Problem | 29 |
Insufficient Heating | 28 |
Temperature Problem | 21 |
Material Erosion | 15 |
Leak / Splash | 13 |
Defective Device | 9 |
Electrode | 8 |
No Apparent Adverse Event | 8 |
Device Displays Incorrect Message | 4 |
Insufficient Information | 4 |
Detachment Of Device Or Device Component | 3 |
Crack | 3 |
Overheating Of Device | 3 |
Electrical /Electronic Property Problem | 3 |
Smoking | 3 |
Fracture | 3 |
Communication Or Transmission Problem | 3 |
Device Operates Differently Than Expected | 3 |
Sparking | 2 |
Melted | 2 |
High Impedance | 2 |
Residue After Decontamination | 1 |
Cannula | 1 |
Use Of Device Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Contamination With Body Fluid | 1 |
Corroded | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Impedance Problem | 1 |
Peeled / Delaminated | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Detachment Of Device Component | 1 |
Device Issue | 1 |
Material Protrusion / Extrusion | 1 |
Generator | 1 |
Loss Of Power | 1 |
| Total Device Problems | 432 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cosman Medical, LLC | II | Feb-22-2018 |
| 2 | Halyard Health, Inc | II | Aug-11-2016 |
| 3 | Kimberly-Clark Corporation | II | Jan-28-2014 |
| 4 | Neurotherm, Inc. | II | Mar-24-2016 |