Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart D — Prosthetic Devices](/submissions/GU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 876.3630](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3630) → FTQ — Prosthesis, Penis, Rigid Rod

# FTQ · Prosthesis, Penis, Rigid Rod

_Gastroenterology, Urology · 21 CFR 876.3630 · Class 2_

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

## Overview

- **Product Code:** FTQ
- **Device Name:** Prosthesis, Penis, Rigid Rod
- **Regulation:** [21 CFR 876.3630](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3630)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **Implant:** yes

## Identification

A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

## Classification Rationale

Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”

## Special Controls

The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K983015](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FTQ/K983015.md) | VIRILIS PENILE PROSTHESIS | Specialty Surgical Products, Inc. | Feb 5, 1999 | SESE |
| [K830667](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FTQ/K830667.md) | SILICONE-SILVER PENILE PROSTHESIS-ESK | Dacomed Corp. | Oct 20, 1983 | SESE |

## Top Applicants

- Dacomed Corp. — 1 clearance
- Specialty Surgical Products, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com