← Product Code [ESW](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW) · K920218

# ESOPHAGEAL Z-STENT (K920218)

_Wilson-Cook Medical, Inc. · ESW · Feb 9, 1994 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/ESW/K920218

## Device Facts

- **Applicant:** Wilson-Cook Medical, Inc.
- **Product Code:** [ESW](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW.md)
- **Decision Date:** Feb 9, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3610
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

## Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/ESW/K920218](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/ESW/K920218)

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