Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart D — Prosthetic Devices](/submissions/GU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 876.3350](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3350) → JCW — Prosthesis, Penis, Inflatable

# JCW · Prosthesis, Penis, Inflatable

_Gastroenterology, Urology · 21 CFR 876.3350 · Class 3_

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

## Overview

- **Product Code:** JCW
- **Device Name:** Prosthesis, Penis, Inflatable
- **Regulation:** [21 CFR 876.3350](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3350)
- **Device Class:** 3
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **Implant:** yes

## Identification

A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [N970012](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/JCW/N970012.md) | AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES | Boston Scientific Corp | Nov 2, 1998 | APPR |

## Top Applicants

- Boston Scientific Corp — 1 clearance

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

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