← Product Code [FTQ](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FTQ) · K830667

# SILICONE-SILVER PENILE PROSTHESIS-ESK (K830667)

_Dacomed Corp. · FTQ · Oct 20, 1983 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FTQ/K830667

## Device Facts

- **Applicant:** Dacomed Corp.
- **Product Code:** [FTQ](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FTQ.md)
- **Decision Date:** Oct 20, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.3630
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

## Special Controls

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

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FTQ/K830667](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FTQ/K830667)

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