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510(k) K041648

NITI-S STENT & INTRODUCER, MODEL EOXXXX by Taewoong Medical Co., Ltd. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2005
Date Received
June 17, 2004
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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  • K233837 — Agile Esophageal Stent System (April 4, 2024)
  • K240522 — Esophageal TTS Stent (March 22, 2024)
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  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)
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