510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042132Substantially Equivalent

Novasys Transurethral RF System

Novasys Medical, Inc., Newark CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K042132 is the FDA 510(k) clearance record for NOVASYS TRANSURETHRAL RF SYSTEM, a class II device, cleared for Novasys Medical, Inc. on under FDA product code NVJ (Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women). FDA's definition for product code NVJ reads: "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". FDA records list 5 510(k) clearances for Novasys Medical, Inc., from to . As of , FDA records show one recall naming K042132.

Clearance record

Decision date
Received
(134 days to decision)
Product code
NVJ Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Novasys Medical, Inc. 39684 Eureka Dr., Newark CA
510(k) summary
Statement
Third party review
No

Clearances, product code NVJ

Trailing 12 months

FDA records hold no clearances under product code NVJ in the trailing twelve months.

FDA records show no clearances under product code NVJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260