Product code FAG

Device name: Prosthesis, Urethral Sphincter
Medical specialty: Unknown
Device class: 3
Review panel: GU
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K912934	AMS SPHINCTER 800 URINARY PROSTHESIS	American Medical Systems, Inc.	1992-03-18
K821627	THE ARTIFICIAL URINARY SPHINCTER	American Medical Systems, Inc.	1982-08-10