# External Urethral Occluder, Urinary Incontinence-Control, Female
> **Product code: MNG** · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5160
## Classification
- **FDA Product Code:** MNG
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 876.5160
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Intended to prevent or decrease episodes of urine leakage in women with stress incontinence.  Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage.  Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.

## Market data
- **Cleared 510(k) submissions:** 7
- **Registered establishments:** 6
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=MNG)
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