| Device Type ID | 3656 |
| Device Name | Generator, Lesion, Radiofrequency |
| Regulation Description | Radiofrequency Lesion Generator. |
| 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 | 882.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXD |
| 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 | 3656 |
| Device | Generator, Lesion, Radiofrequency |
| Product Code | GXD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radiofrequency Lesion Generator. |
| CFR Regulation Number | 882.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BAYLIS MEDICAL COMPANY INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIEVANT MEDSYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 80 |
Temperature Problem | 76 |
Device Operates Differently Than Expected | 38 |
Failure To Power Up | 25 |
Device Displays Incorrect Message | 24 |
Impedance Problem | 19 |
Communication Or Transmission Problem | 12 |
No Display / Image | 10 |
High Impedance | 9 |
Therapeutic Or Diagnostic Output Failure | 7 |
Failure To Deliver Energy | 6 |
Unexpected Shutdown | 5 |
Generator | 5 |
Display Or Visual Feedback Problem | 4 |
Smoking | 4 |
Electrical /Electronic Property Problem | 4 |
Intermittent Communication Failure | 4 |
Device Inoperable | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Insufficient Heating | 3 |
Device Remains Activated | 3 |
Insufficient Information | 3 |
Noise, Audible | 3 |
Failure To Shut Off | 3 |
Output Problem | 3 |
Thermal Decomposition Of Device | 3 |
Computer Software Problem | 3 |
Erratic Or Intermittent Display | 3 |
No Device Output | 2 |
Overheating Of Device | 2 |
Break | 2 |
Use Of Device Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Low Impedance | 2 |
Device Sensing Problem | 2 |
Display Difficult To Read | 2 |
Inappropriate Shock | 2 |
Unintended Electrical Shock | 2 |
Bent | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Wrinkled | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Material Twisted / Bent | 1 |
Device Stops Intermittently | 1 |
Failure To Capture | 1 |
Improper Device Output | 1 |
Pad | 1 |
Device Difficult To Setup Or Prepare | 1 |
Electrical Power Problem | 1 |
Probe | 1 |
Loose Or Intermittent Connection | 1 |
Positioning Problem | 1 |
Switch, Push Button | 1 |
Alarm, Audible | 1 |
Device Alarm System | 1 |
Electromagnetic Interference | 1 |
Fuse | 1 |
Detachment Of Device Component | 1 |
Image Display Error / Artifact | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Arcing | 1 |
Failure Of Device To Self-Test | 1 |
| Total Device Problems | 412 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Neurotherm, Inc. | II | Apr-09-2016 |
| 2 | Stryker Instruments Div. Of Stryker Corporation | III | Nov-16-2016 |