FAG · Class III

FDA Product Code FAG: Prosthesis, Urethral Sphincter

Leading manufacturers include American Medical Systems, Inc..

2
Total
2
Cleared
163d
Avg days
1982
Since

FDA 510(k) Cleared Prosthesis, Urethral Sphincter Devices (Product Code FAG)

2 devices
1–2 of 2
Cleared Mar 18, 1992
AMS SPHINCTER 800 URINARY PROSTHESIS
K912934
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Aug 10, 1982
THE ARTIFICIAL URINARY SPHINCTER
K821627
American Medical Systems, Inc.
Gastroenterology & Urology · 69d

About Product Code FAG - Regulatory Context