Product code FAG— Unknown

AMS SPHINCTER 800 URINARY PROSTHESIS

Classification name: Prosthesis, Urethral Sphincter
Device class: Class 3
Advisory panel: Unknown
Total cleared: 2
First cleared: 1982-08-10
Most recent: 1992-03-18

Market context for product code FAG

FDA has cleared 2 devices under product code FAG between 1982 and 1992, filed by 1 applicant company. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Clearances per year

19921 clearance
19821 clearance

Top applicants under product code FAG

American Medical Systems, Inc.2 clearances

Recent clearances under product code FAG

K912934 — AMS SPHINCTER 800 URINARY PROSTHESISAmerican Medical Systems, Inc.·1992-03-18
K821627 — THE ARTIFICIAL URINARY SPHINCTERAmerican Medical Systems, Inc.·1982-08-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.