FAG — Prosthesis, Urethral Sphincter Class III

FDA Device Classification

FDA product code FAG covers "Prosthesis, Urethral Sphincter", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FAG
Device Class
Class III
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K912934american medical systemsAMS SPHINCTER 800 URINARY PROSTHESISMarch 18, 1992
K821627american medical systemsTHE ARTIFICIAL URINARY SPHINCTERAugust 10, 1982