Definition: Ablation Of Soft Tissue
| Device Type ID | 5793 |
| Device Name | Low Energy Direct Current Thermal Ablation System |
| Physical State | It Includes The LEDC Generator, Electrodes And Accessories |
| Technical Method | It Applies A Low Energy Direct Current (LEDC) Pulse Or Series Of Pulses Between Two Electrodes To Cause An Ablation Effect To Occur |
| Target Area | Soft Tissue Including Cardiac And Smooth Muscle |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5793 |
| Device | Low Energy Direct Current Thermal Ablation System |
| Product Code | OAB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
Device Stops Intermittently | 4 |
Insufficient Information | 4 |
Failure Of Device To Self-Test | 3 |
Communication Or Transmission Problem | 2 |
Device Operational Issue | 1 |
Device Remains Activated | 1 |
No Display / Image | 1 |
Failure To Auto Stop | 1 |
Material Separation | 1 |
| Total Device Problems | 25 |