Last synced on 27 January 2023 at 11:04 pm

Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

Page Type
Product Code
Definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Physical State
radiofrequency generator, applicator, software
Technical Method
A generator supplies radiofrequency energy through a connected applicator with an electrode tip
Target Area
pelvic tissue
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4400 Electrosurgical cutting and coagulation device and accessories

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.

Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

Page Type
Product Code
Definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Physical State
radiofrequency generator, applicator, software
Technical Method
A generator supplies radiofrequency energy through a connected applicator with an electrode tip
Target Area
pelvic tissue
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4400 Electrosurgical cutting and coagulation device and accessories

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.