← Product Code [MNG](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG) · K010365

# ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (K010365)

_Personal Products Co. · MNG · Apr 30, 2001 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K010365

## Device Facts

- **Applicant:** Personal Products Co.
- **Product Code:** [MNG](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG.md)
- **Decision Date:** Apr 30, 2001
- **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/MNG/K010365](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K010365)

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