# FAG · Prosthesis, Urethral Sphincter

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/FAG

## Overview

- **Product Code:** FAG
- **Device Name:** Prosthesis, Urethral Sphincter
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K912934](/device/K912934.md) | AMS SPHINCTER 800 URINARY PROSTHESIS | American Medical Systems, Inc. | Mar 18, 1992 | SESE |
| [K821627](/device/K821627.md) | THE ARTIFICIAL URINARY SPHINCTER | American Medical Systems, Inc. | Aug 10, 1982 | SESE |

## Top Applicants

- American Medical Systems, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/FAG](https://fda.innolitics.com/productcode/FAG)

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