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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K233939
Device Name Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
Applicant
Boston Scientific
300 Boston Scientific Way
Malborough,  MA  01752
Applicant Contact Yanine Garcia-Quezada
Correspondent
Boston Scientific
300 Boston Scientific Way
Malborough,  MA  01752
Correspondent Contact Yanine Garcia-Quezada
Regulation Number878.3610
Classification Product Code
ESW  
Date Received12/14/2023
Decision Date 04/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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