Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3610](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3610) → JCQ — Prosthesis, Esophagus

# JCQ · Prosthesis, Esophagus

_General, Plastic Surgery · 21 CFR 878.3610 · Class 2_

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

## Overview

- **Product Code:** JCQ
- **Device Name:** Prosthesis, Esophagus
- **Regulation:** [21 CFR 878.3610](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3610)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## 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.

## Classification Rationale

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

## Special Controls

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

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K896390](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCQ/K896390.md) | WILSON-COOK ESOPHAGEAL PROSTHESIS | Wilson-Cook Medical, Inc. | Dec 27, 1989 | SESE |

## Top Applicants

- Wilson-Cook Medical, Inc. — 1 clearance

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

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