FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K112522
Device Name FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Applicant
FLEXIBLE STENTING SOLUTIONS, INC.
23 christopher way
suite 103
eatontown, 
NJ 
07724

Applicant Contact joseph c griffin iii
Correspondent
FLEXIBLE STENTING SOLUTIONS, INC.
23 christopher way
suite 103
eatontown, 
NJ 
07724

Correspodent Contact joseph c griffin iii
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 08/31/2011
Decision Date 12/30/2011
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls