510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MNGClass I

External Urethral Occluder, Urinary Incontinence-Control, Female

21 CFR 876.5160 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MNG is the FDA product code for External Urethral Occluder, Urinary Incontinence-Control, Female, a class I device type, regulated under 21 CFR 876.5160. FDA's definition for this code reads: "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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MNG
Device name
External Urethral Occluder, Urinary Incontinence-Control, Female
FDA 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.
Regulation
21 CFR 876.5160
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code MNG

By decision year
7 clearances under product code MNG with a decision year between 1996 and 2001, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MNG by decision year
YearClearances
19961
19972
19982
19991
20011

Applicants with the most clearances

Product code MNG
Applicants holding the most 510(k) clearances under product code MNG
ApplicantClearances
Insight Medical Corp.2
Nebl, Inc.2
Advanced Surgical Intervention, Inc.1
Personal Products Co.1
Uromed Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code