FDA product code NVJ

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

General, Plastic Surgery·Class 2·21 CFR 878.4400
US regulatory classifications
US Product Code (FDA)
NVJ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4400
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.