UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION


Device Classification Name

snare, flexible

510(k) Number K103611
Device Name UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd.
mentor, 
OH 
44060

Applicant Contact carroll l martin
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd.
mentor, 
OH 
44060

Correspodent Contact carroll l martin
Regulation Number 876.4300
Classification Product Code
FDI  
Date Received 12/09/2010
Decision Date 05/09/2011
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