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HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201160

by M.I.Tech Co., Ltd.

Identifiers

510(k) Number
K201160 FDA 510(k)
FDA Product Code
ESW 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 Esophagus (CCC) and HANAROSTENT Esophagus (NCN) are esophageal prostheses designed to maintain luminal patency. These devices are intended for use in esophageal strictures caused by malignant tumors, both intrinsic and extrinsic, as well as for occluding esophageal fistulas. Classified as a Class II device under FDA regulations (878.3610), they are intended for endoscopic placement within the esophagus to restore and preserve passage through narrowed or obstructed areas.

These stents are supplied in a sterile, single-use configuration and are intended for use in clinical settings such as endoscopy suites or operating rooms. They are available in multiple reference codes (e.g., 1721676, 3009526575) and are regulated under the FDA’s 510(k) clearance process, with a decision date of July 23, 2021. The HANAROSTENT Esophagus (CCC) and (NCN) variants are intended for general plastic surgery applications, as noted in the advisory committee review. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What is the HANAROSTENT Esophagus (CCC) and (NCN) intended for?

The HANAROSTENT Esophagus (CCC) and (NCN) are esophageal prostheses intended to maintain luminal patency in esophageal strictures caused by malignant tumors, both intrinsic and extrinsic, and to occlude esophageal fistulas. They are designed for endoscopic placement within the esophagus to restore and preserve passage through narrowed or obstructed areas.

How is the HANAROSTENT Esophagus supplied, and is it reusable?

The HANAROSTENT Esophagus (CCC) and (NCN) are supplied in a sterile, single-use configuration. They are not intended for reuse and must be discarded after one use to maintain sterility and prevent cross-contamination, as specified in the device description.

What regulatory pathway was used for the HANAROSTENT Esophagus (CCC) and (NCN), and when was it cleared?

The HANAROSTENT Esophagus (CCC) and (NCN) were cleared through the FDA’s 510(k) premarket notification process, with a decision date of July 23, 2021, and were found substantially equivalent to a predicate device under regulation number 878.3610.

What reference codes or identifiers are associated with the HANAROSTENT Esophagus (CCC) and (NCN)?

The HANAROSTENT Esophagus (CCC) and (NCN) are associated with multiple reference codes, including 1721676 and 3009526575, among others listed in the openfda field, which are used for device identification and tracking in regulatory and inventory systems.

Where should the HANAROSTENT Esophagus be stored and handled?

The HANAROSTENT Esophagus (CCC) and (NCN) must be stored and handled in compliance with sterile medical device protocols to maintain their sterility and integrity until use, as stated in the device description under storage and handling requirements.

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. Sources consulted: HANAROSTENT™ Esophagus Line of Metal Stents - Olympus America, HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (K201160 ..., HANAROSTENT® Esophagus Through-the-Scope (TTS)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
M.I.Tech Co., Ltd.

Sources (1)

  • FDA 510(k) K201160 24 fields · synced Sep 19, 2026