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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K171454
Device Name Interject Injection Therapy Needle Catheter
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Tara Paul
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Tara Paul
Regulation Number876.1500
Classification Product Code
FBK  
Date Received05/17/2017
Decision Date 07/07/2017
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
Recalls CDRH Recalls
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