STRYKER VIDEO URETEROSCOPE


Device Classification Name

ureteroscope and accessories, flexible/rigid

510(k) Number K121112
Device Name STRYKER VIDEO URETEROSCOPE
Applicant
Stryker Endoscopy
5900 optical ct.
san jose, 
CA 
95138

Applicant Contact kevin potgieter, rac
Correspondent
Stryker Endoscopy
5900 optical ct.
san jose, 
CA 
95138

Correspodent Contact kevin potgieter, rac
Regulation Number 876.1500
Classification Product Code
FGB  
Date Received 04/12/2012
Decision Date 09/12/2012
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