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

Product Code: MUK

General & Plastic Surgery Microwave Diathermy Machines

Definition: For Shrinkage And Stabilization Of Female Pelvic Tissue For Treatment Of Stress Urinary Incontinence.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4400


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as MUK

2173Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic TissueElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

2173Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic TissueElectrosurgical Cutting And Coagulation Device And Accessories.

Pre-market Notifications for MUK

K020952SURX RF SYSTEMSURX, INC.
K020126MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)SURX, INC.
K011190SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)SURX, INC.

Maude Adverse Events

RF DENERVATION, 15 CM SPINE PROBESMITH & NEPHEW INC., ENDOSCOPY DIVISION2007-02-27

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