INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER


Device Classification Name

unit, electrosurgical, endoscopic (with or without accessories)

510(k) Number K110887
Device Name INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
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 876.4300
Classification Product Code
KNS  
Date Received 03/30/2011
Decision Date 04/14/2011
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