Cleared Traditional

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

K180180 · M.I. Tech Co., Ltd. · Gastroenterology & Urology
Nov 2018
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K180180 is an FDA 510(k) clearance for the HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM 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 November 2, 2018, 283 days after receiving the submission on January 23, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K180180 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2018
Decision Date November 02, 2018
Days to Decision 283 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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