510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FAGClass III

Prosthesis, Urethral Sphincter

Unknown
FDA source (opens on fda.gov)

FAG is the FDA product code for Prosthesis, Urethral Sphincter, a class III device type. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FAG
Device name
Prosthesis, Urethral Sphincter
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code FAG

By decision year
2 clearances under product code FAG with a decision year between 1982 and 1992, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FAG by decision year
YearClearances
19821
19921

Applicants with the most clearances

Product code FAG
Applicants holding the most 510(k) clearances under product code FAG
ApplicantClearances
American Medical Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code