| Device |
transurethral electrosurgical unit, benign prostatic hyperplasia |
| Regulation Description |
Endoscopic electrosurgical unit and accessories. |
| Definition |
Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia |
| Physical State |
The device consists primarily of a radio frequency generator and an applicator. The applicator is inserted into the urethra and positions the electrodes appropriately for delivery of RF energy transurethrally to the prostate. |
| Technical Method |
Radio frequency energy is applied to the prostate using electrodes. Resistive heating of the prostatic tissue leads to necrotic death or direct ablation depending on the temperatures achieved. |
| Target Area |
Prostate |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OEJ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.4300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
