Cleared Traditional

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

K200860 · M.I. Tech Co., Ltd. · Gastroenterology & Urology
May 2020
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K200860 is an FDA 510(k) clearance for the HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN), a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on May 20, 2020, 49 days after receiving the submission on April 1, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K200860 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2020
Decision Date May 20, 2020
Days to Decision 49 days
Submission Type Traditional
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

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