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510(k) K211960

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2021
Date Received
June 24, 2021
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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  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
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  • K240522 — Esophageal TTS Stent (March 22, 2024)
  • K223266 — Hilzo Esophageal Stents (January 16, 2024)
  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)
  • K211706 — Esophageal TTS Stent (October 8, 2021)