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HanaroStent LowAx Colon/Rectum (NNN)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190141

by M.I.Tech Co., Ltd.

Identifiers

510(k) Number
K190141 FDA 510(k)
FDA Product Code
MQR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3610 FDA 510(k)
Regulation Number
878.3610 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HanaroStent LowAx Colon/Rectum (NNN) is a Colonic, Metallic, Expandable Stent, classified as a Class II medical device. This self-expanding stent is designed to provide mechanical support and maintain patency in the low axial colon or rectum, particularly in cases of obstruction or stricture.

This stent is supplied sterile and intended for single-use. It is regulated under the FDA’s 510(k) pathway with Special 510(k) clearance and falls under the Medical Device Directive (MDD). The device is available in multiple reference codes and is intended for use in clinical settings where endoscopic placement is feasible, adhering to standard sterile techniques.

Frequently asked questions

What is the primary clinical purpose of the HanaroStent LowAx Colon/Rectum (NNN) and where is it typically placed in the body?

The HanaroStent LowAx Colon/Rectum (NNN) is designed to provide mechanical support and maintain patency in the low axial colon or rectum, particularly in cases of obstruction or stricture. It is a self-expanding metallic stent intended for endoscopic placement within these specific regions of the gastrointestinal tract.

Is the HanaroStent LowAx Colon/Rectum (NNN) reusable or intended for single-use, and how is it supplied?

The HanaroStent LowAx Colon/Rectum (NNN) is sterile and intended for single-use only. It is supplied pre-sterilized, adhering to standard sterile techniques required for endoscopic procedures, ensuring patient safety and compliance with clinical protocols.

How many different reference codes or models are available for the HanaroStent LowAx Colon/Rectum (NNN), and how would I identify them?

The HanaroStent LowAx Colon/Rectum (NNN) is available in multiple reference codes, specifically listed as FEI numbers 3002807036, 3002807314, 3009526575, 3003902943, 1000121056, 3040096051, 3010273872, 3005099803, 3008146331, 3011458193, 3005580113, and 3001845648. These codes correspond to distinct models or variations, which can be cross-referenced with the registration numbers (e.g., 3002807314) for precise identification.

What regulatory pathways does the HanaroStent LowAx Colon/Rectum (NNN) follow, and how was its equivalence determined?

The HanaroStent LowAx Colon/Rectum (NNN) is regulated under the FDA’s 510(k) pathway, specifically granted Special 510(k) clearance with a decision code of SESE (Substantially Equivalent). Its equivalence was determined through a review by the General, Plastic Surgery advisory committee (SU), confirming it meets the performance criteria of existing predicate devices under product code MQR and regulation number 878.3610.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
M.I.Tech Co., Ltd.

Sources (2)

  • FDA 510(k) K190141 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026