Last synced on 2 December 2022 at 11:04 pm

Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

Page Type
Product Code
Definition
Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.
Physical State
Consists of radio frequency probe and generator and accessories.
Technical Method
Functions within a system.
Target Area
Bladder neck and proximal urethra
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
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.

Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

Page Type
Product Code
Definition
Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.
Physical State
Consists of radio frequency probe and generator and accessories.
Technical Method
Functions within a system.
Target Area
Bladder neck and proximal urethra
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
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.