Cleared Traditional

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (K183616) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183616 · M.I. Tech Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
15d
Days
Class 2
Risk

K183616 is an FDA 510(k) clearance for the HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN). Classified as Stent, Colonic, Metallic, Expandable (product code MQR), Class II - Special Controls.

Submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on January 10, 2019 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all M.I. Tech Co., Ltd. devices

Submission Details

510(k) Number K183616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQR Stent, Colonic, Metallic, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Namsa
Beryl St. Jeanne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQR Stent, Colonic, Metallic, Expandable

All 12
Devices cleared under the same product code (MQR) and FDA review panel - the closest regulatory comparables to K183616.
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · Boston Scientific Corporation · Aug 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
K200257 · Boston Scientific Corporation · Apr 2020
HANAROSTENT LowAx Colon/Rectum (NNN)
K190141 · M.I. Tech Co., Ltd. · Mar 2019
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
K180180 · M.I. Tech Co., Ltd. · Nov 2018
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · Boston Scientific Corp · Sep 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
K060323 · Boston Scientific Corporation · May 2006