510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
MUKClass II

Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

21 CFR 878.4400 / General, Plastic Surgery
FDA source (opens on fda.gov)

MUK is the FDA product code for Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MUK
Device name
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
FDA definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code MUK

By decision year
3 clearances under product code MUK with a decision year between 2002 and 2002, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MUK by decision year
YearClearances
20023

Applicants with the most clearances

Product code MUK
Applicants holding the most 510(k) clearances under product code MUK
ApplicantClearances
Surx, Inc.2
Surx, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MUK.