← Product Code [FHA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA) · K885323

# DACOMED EXTERNAL MALE CONTINENCE DEVICE (K885323)

_Dacomed Corp. · FHA · Feb 8, 1989 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K885323

## Device Facts

- **Applicant:** Dacomed Corp.
- **Product Code:** [FHA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA.md)
- **Decision Date:** Feb 8, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5160
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K885323](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K885323)

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