RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM

• K Number: K010068
• Device Name: RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
• Manufacturer: RUSCH INTL.
• Date Cleared: 2001-02-08 ( 31 days)
• Product Code: ESW
• Regulation Number: 878.3610

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Summary

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