Product code MUK

Device name: Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.4400
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K020952	SURX RF SYSTEM	Surx, Inc.	2002-05-30
K020126	MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)	Surx, Inc.	2002-03-15
K011190	SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)	Surx, Inc.	2002-01-08

Related 510(k) Records#