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Coverd Gianturco-Rosch Esophageal Z-Stent

FDA 510(k)

Class II (US FDA 510(k))

510(k) K945201

by Cook, Inc.

Identifiers

510(k) Number
K945201 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 Covered Gianturco-Rosch Esophageal Z-Stent is a self-expandable metallic stent designed for esophageal use. It features a silicone covering to provide additional support and reduce migration risk in treating malignant obstructions within the esophagus. This device falls under the classification of an esophageal prosthesis, intended to restore or maintain patency in obstructed segments of the esophagus. Its Z-shaped design allows for radial expansion and conformance to the esophageal anatomy, ensuring stability and effective lumen maintenance.

The stent is supplied as a single-use device and is intended for use in clinical settings such as endoscopy suites or operating rooms. It is regulated under FDA 510(k) clearance (K945201) and falls under the classification of Class II (ESW product code) under regulation 878.3610. The device is not explicitly stated to be MRI-safe or reusable, and its sterility is implied through standard medical device packaging for single-use implants. Multiple reference numbers (e.g., 1721676, 3009526575) indicate regulatory tracking and distribution records, but no additional details on storage conditions or specific sizes beyond the model designation are provided.

Frequently asked questions

What is the Coverd Gianturco-Rosch Esophageal Z-Stent used for?

The Coverd Gianturco-Rosch Esophageal Z-Stent is designed to restore or maintain patency in obstructed segments of the esophagus caused by malignant obstructions. Its Z-shaped, self-expandable metallic structure with a silicone covering provides radial support and reduces migration risk, ensuring effective lumen maintenance in clinical settings like endoscopy suites or operating rooms.

How is the Coverd Gianturco-Rosch Esophageal Z-Stent supplied and intended for use?

This device is supplied as a single-use, sterile implant intended exclusively for clinical use. It is not reusable and must be used in controlled environments such as endoscopy suites or operating rooms to treat esophageal obstructions. The sterility is ensured through standard medical device packaging for single-use implants.

Is the Coverd Gianturco-Rosch Esophageal Z-Stent MRI-safe?

The device’s MRI safety is not explicitly stated in the available information. Clinicians should consult manufacturer guidelines or technical data sheets before using this stent in MRI environments to avoid potential risks.

What regulatory approvals does the Coverd Gianturco-Rosch Esophageal Z-Stent hold?

The Coverd Gianturco-Rosch Esophageal Z-Stent holds FDA 510(k) clearance under the reference number K945201. It is classified as a Class II device under the product code ESW (Esophageal Prosthesis) and regulation number 878.3610. This clearance indicates it is deemed substantially equivalent to a legally marketed predicate device.

Are there different sizes or models available for the Coverd Gianturco-Rosch Esophageal Z-Stent?

The available data lists multiple reference numbers (e.g., 1721676, 3009526575) associated with this device, which likely correspond to different lot or batch tracking for regulatory and distribution purposes. However, specific details on sizes, models, or variations beyond the model designation (e.g., Z-shaped design) are not provided in the available information.

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: K945201 FDA 510(k) - COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT, PDF K945201 - Coverd Gianturco-rosch Esophageal Z-stent, COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT 510(k)… - FDA.report, Treatment of Malignant Esophageal Obstructions with Covered Metallic Z ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cook, Inc.

Sources (1)

  • FDA 510(k) K945201 24 fields · synced Oct 6, 2026