EXPECT ENDOSCOPIC ASPIRATION NEEDLE


Device Classification Name

endoscopic ultrasound system, gastroenterology-urology

510(k) Number K110030
Device Name EXPECT ENDOSCOPIC ASPIRATION NEEDLE
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact ashley pyle
Regulation Number 876.1500
Classification Product Code
ODG  
Date Received 01/05/2011
Decision Date 01/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls