Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device electrosurgical radiofrequency system, stress urinary incontinence, female, transvaginal or laparoscopic, pelvic tissue
Regulation Description Electrosurgical cutting and coagulation device and accessories.
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 Reproductive, Gynecology and Urology Devices (DHT3B)
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
-
-