Cleared Special

HANAROSTENT LowAx Colon/Rectum (NNN)

K190141 · M.I. Tech Co., Ltd. · Gastroenterology & Urology
Mar 2019
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K190141 is an FDA 510(k) clearance for the HANAROSTENT LowAx Colon/Rectum (NNN), a Stent, Colonic, Metallic, Expandable (Class II — Special Controls, product code MQR), submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on March 7, 2019, 37 days after receiving the submission on January 29, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K190141 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2019
Decision Date March 07, 2019
Days to Decision 37 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MQR — Stent, Colonic, Metallic, Expandable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3610

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