Cleared Traditional

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

K183616 · M.I. Tech Co., Ltd. · Gastroenterology & Urology
Jan 2019
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K183616 is an FDA 510(k) clearance for the HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (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 January 10, 2019, 15 days after receiving the submission on December 26, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K183616 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2018
Decision Date January 10, 2019
Days to Decision 15 days
Submission Type Traditional
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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