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K233939

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

510(k) number
K233939
Device name
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
Applicant
Boston Scientific MA · US
Product code
ESW — Prosthesis, Esophageal
Decision date
2024-04-29
Date received
2023-12-14
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain

Also available from FDA: K233939.pdf

Official FDA record: K233939
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.