← Product Code [FAE](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE) · K871653

# DURAPHASE PENILE PROSTHESIS (K871653)

_Dacomed Corp. · FAE · Sep 18, 1987 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K871653

## Device Facts

- **Applicant:** Dacomed Corp.
- **Product Code:** [FAE](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE.md)
- **Decision Date:** Sep 18, 1987
- **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.”

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K871653](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K871653)

**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