American Medical Systems - FDA 510(k) Cleared Devices

American Medical Systems, is a medical device manufacturer with a manufacturing facility in Minnetonka, US. The company specialized in surgical implants and minimally invasive treatment systems across multiple therapeutic areas.

American Medical Systems received 10 FDA 510(k) clearances from 10 total submissions between 2008 and 2014. The company's cleared devices focused primarily on Obstetrics & Gynecology applications, including prolapse repair systems and surgical meshes, alongside devices in General & Plastic Surgery and Gastroenterology & Urology. The company is inactive and maintains a historical regulatory record only.

Notable cleared products include prolapse repair systems (ELEVATE, APOGEE, PERIGEE, SPARC, MONARC), single-incision sling systems (MINIARC PRO), lithotripsy laser fibers (SUREFLEX), and fiber optic delivery systems. These devices represent core technologies in pelvic floor reconstruction and urological treatment.

Explore the complete device names, product codes, and clearance dates in the 510(k) database to review American Medical Systems' full regulatory history.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.