← Product Code [FAE](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE) · K803111

# ERECTAID (K803111)

_Burditt & Calkins-Siemens-Elema · FAE · Jan 23, 1981 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K803111

## Device Facts

- **Applicant:** Burditt & Calkins-Siemens-Elema
- **Product Code:** [FAE](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE.md)
- **Decision Date:** Jan 23, 1981
- **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/FAE/K803111](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K803111)

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