Atlas FDA

MUK

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
FDA definition
For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
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RecordFirmDateBuilder
SURX RF SYSTEM (K020952)Surx, Inc.2002-05-30+ Add
MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) (K020126)Surx, Inc.2002-03-15+ Add
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) (K011190)Surx, Inc.2002-01-08+ Add

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Every clearance here is in the API, with alerts when new ones post.