Cleared Special

HANAROSTENT ESOPHAGUS (CCC)

K093537 · M.I. Tech Co., Ltd. · Gastroenterology & Urology
Jun 2010
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K093537 is an FDA 510(k) clearance for the HANAROSTENT ESOPHAGUS (CCC), a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by M.I. Tech Co., Ltd. (Buena Park, US). The FDA issued a Cleared decision on June 4, 2010, 200 days after receiving the submission on November 16, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K093537 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2009
Decision Date June 04, 2010
Days to Decision 200 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code ESW — Prosthesis, Esophageal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3610

Similar Devices — ESW Prosthesis, Esophageal

All 58
Niti-S Esophageal Stent; Esophageal TTS Stent
K243619 · Taewoong Medical Co., Ltd. · Oct 2025
HANAROSTENT Esophagus Upper (CCC)
K253327 · M.I. Tech Co., Ltd. · Oct 2025
Resilience Fully Covered Esophageal Stent System
K251265 · Merit Medical Systems, Inc. · Jul 2025
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
K233939 · Boston Scientific · Apr 2024
Agile Esophageal Stent System
K233837 · Boston Scientific Corporation · Apr 2024
Esophageal TTS Stent
K240522 · Taewoong Medical · Mar 2024