FDA product code MNG: External Urethral Occluder, Urinary Incontinence-Control, Female
MNG is the FDA product code for external urethral occluder, urinary incontinence-control, female. It is a Class I device, regulated under 21 CFR 876.5160 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under MNG, from 5 different applicants. The average 510(k) review took 183 days (median 176).
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.
Classification
| Field | Value |
|---|---|
| Device name | External Urethral Occluder, Urinary Incontinence-Control, Female |
| Device class | Class I |
| Regulation | 21 CFR 876.5160 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MNG clearance
Top MNG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nebl, Inc. | 2 | 1999-03-05 |
| Insight Medical Corp. | 2 | 1998-02-12 |
| Personal Products Co. | 1 | 2001-04-30 |
| Uromed Corp. | 1 | 1998-03-31 |
| Advanced Surgical Intervention, Inc. | 1 | 1996-05-08 |
Most recent MNG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010365 | Personal Products Co. | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | 2001-04-30 | 82 |
| K983164 | Nebl, Inc. | RESTORE (AKA RE/STOR) | 1999-03-05 | 176 |
| K974600 | Uromed Corp. | UROMED PATCH | 1998-03-31 | 112 |
| K974645 | Insight Medical Corp. | FEMASSIST FLEXIBLE | 1998-02-12 | 62 |
| K971359 | Nebl, Inc. | RESTORE (A.K.A. CAPSURE) | 1997-11-14 | 217 |
Recalls for MNG devices
openFDA lists no recalls for product code MNG.
Frequently asked questions
What is FDA product code MNG?
MNG is the FDA product code for external urethral occluder, urinary incontinence-control, female. It is a Class I device, regulated under 21 CFR 876.5160 and reviewed by the Gastroenterology and Urology panel.
What device class is MNG?
Class I, regulation 21 CFR 876.5160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MNG?
Across 7 cleared submissions the average was 183 days from receipt to decision (median 176).
Which companies have the most MNG clearances?
Nebl, Inc. (2); Insight Medical Corp. (2); Personal Products Co. (1); Uromed Corp. (1); Advanced Surgical Intervention, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MNG
- Run a recall and safety report across every MNG manufacturer
- Watch product code MNG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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