Product code NVJ— General, Plastic Surgery

NOVASYS TRANSURETHRAL RF SYSTEM

Classification name: Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Total cleared: 1
First cleared: 2004-12-21
Most recent: 2004-12-21

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code NVJ under 21 CFR 878.4400, via openFDA

Market context for product code NVJ

FDA has cleared 1 device under product code NVJ, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NVJ

Novasys Medical, Inc.1 clearance

Recent clearances under product code NVJ

K042132 — NOVASYS TRANSURETHRAL RF SYSTEMNovasys Medical, Inc.·2004-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.