FOSSA URETERAL STONE SWEEPER


Device Classification Name

stent, ureteral

510(k) Number K021602
Device Name FOSSA URETERAL STONE SWEEPER
Original Applicant
FOSSA INDUSTRIES, INC.
5 whitcomb ave.
ayer, 
MA 
01432

Original Contact pamela papineau
Regulation Number 876.4620
Classification Product Code
FAD  
Subsequent Product Code
FGO  
Date Received 05/15/2002
Decision Date 07/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No