Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart D — Prosthetic Devices](/submissions/GU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 876.3750](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3750) → FAF — Prosthesis, Testicular

# FAF · Prosthesis, Testicular

_Gastroenterology, Urology · 21 CFR 876.3750 · Class 3_

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

## Overview

- **Product Code:** FAF
- **Device Name:** Prosthesis, Testicular
- **Regulation:** [21 CFR 876.3750](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3750)
- **Device Class:** 3
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **Implant:** yes

## Identification

A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P020003](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAF/P020003.md) | COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS | Coloplast Corp. | Jul 19, 2002 | APPR |

## Top Applicants

- Coloplast Corp. — 1 clearance

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

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