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510(k) K180144

Agile Esophageal Stent System by Boston Scientific Corporation — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2018
Date Received
January 18, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

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Other clearances for product code ESW

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  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)
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