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510(k) K240522

Esophageal TTS Stent by Taewoong Medical — Product Code ESW

K240522 is an FDA 510(k) premarket notification submitted by Taewoong Medical for the device "Esophageal TTS Stent". The FDA issued a decision of Substantially Equivalent on March 22, 2024. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2024
Date Received
February 23, 2024
Clearance Type
Special
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

Other clearances for product code ESW

  • K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent Syst (July 10, 2026)
  • K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent (October 30, 2025)
  • K253327 — HANAROSTENT Esophagus Upper (CCC) (October 30, 2025)
  • K251265 — Resilience Fully Covered Esophageal Stent System (July 23, 2025)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K233837 — Agile Esophageal Stent System (April 4, 2024)
  • K223266 — Hilzo Esophageal Stents (January 16, 2024)
  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)
  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)

FDA data resources