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U.S. Department of Health and Human Services

Product Classification

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Device electrosurgical radiofrequency system, stress urinary incontinence, female, transvaginal or laparoscopic, pelvic tissue
Definition For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
Physical State radiofrequency generator, applicator, software
Technical Method A generator supplies radiofrequency energy through a connected applicator with an electrode tip
Target Area pelvic tissue
Regulation Medical Specialty General & Plastic Surgery
Review Panel Gastroenterology/Urology
Product CodeMUK
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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