EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE


Device Classification Name

endoscopic ultrasound system, gastroenterology-urology

510(k) Number K112198
Device Name EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
Applicant
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact ashley pyle
Correspondent
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact ashley pyle
Regulation Number 876.1500
Classification Product Code
ODG  
Subsequent Product Code
FCG  
Date Received 08/01/2011
Decision Date 09/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No