Last synced on 2 December 2022 at 11:04 pm

Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia

Page Type
Product Code
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 and Urology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4300 Endoscopic electrosurgical unit and accessories

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a) Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

(b) Classification. Class II (performance standards).

Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia

Page Type
Product Code
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 and Urology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.4300 Endoscopic electrosurgical unit and accessories

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a) Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

(b) Classification. Class II (performance standards).