DeviceClearance

Product code MUK— General, Plastic Surgery

MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)

Classification name
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

FDA classification definition

“For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence”

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

Market context for product code MUK

FDA has cleared 3 devices under product code MUK, all in 2002, 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 MUK

Recent clearances under product code MUK

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