TISSUE SAMPLING NEEDLE


Device Classification Name

biopsy needle kit

510(k) Number K103694
Device Name TISSUE SAMPLING NEEDLE
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 876.1075
Classification Product Code
FCG  
Date Received 12/17/2010
Decision Date 07/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No