Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5160](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5160) → MNG — External Urethral Occluder, Urinary Incontinence-Control, Female

# MNG · External Urethral Occluder, Urinary Incontinence-Control, Female

_Gastroenterology, Urology · 21 CFR 876.5160 · Class 1_

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

## Overview

- **Product Code:** MNG
- **Device Name:** External Urethral Occluder, Urinary Incontinence-Control, Female
- **Regulation:** [21 CFR 876.5160](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5160)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Classification Rationale

Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K010365](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K010365.md) | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Personal Products Co. | Apr 30, 2001 | SESE |
| [K983164](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K983164.md) | RESTORE (AKA RE/STOR) | Nebl, Inc. | Mar 5, 1999 | SESE |
| [K974600](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K974600.md) | UROMED PATCH | Uromed Corp. | Mar 31, 1998 | SESE |
| [K974645](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K974645.md) | FEMASSIST FLEXIBLE | Insight Medical Corp. | Feb 12, 1998 | SESE |
| [K971359](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K971359.md) | RESTORE (A.K.A. CAPSURE) | Nebl, Inc. | Nov 14, 1997 | SESE |
| [K963858](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K963858.md) | FEMASSIST URINARY DEVICE | Insight Medical Corp. | Oct 21, 1997 | SESE |
| [K954215](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/MNG/K954215.md) | MINIGUARD | Advanced Surgical Intervention, Inc. | May 8, 1996 | SESE |

## Top Applicants

- Insight Medical Corp. — 2 clearances
- Nebl, Inc. — 2 clearances
- Advanced Surgical Intervention, Inc. — 1 clearance
- Personal Products Co. — 1 clearance
- Uromed Corp. — 1 clearance

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

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