Product code MNG

Device name: External Urethral Occluder, Urinary Incontinence-Control, Female
Medical specialty: Gastroenterology, Urology
Device class: 1
Regulation number: 876.5160
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K010365	ORTHO CONTROL FEMALE URINARY CONTROL DEVICE	Personal Products Co.	2001-04-30
K983164	RESTORE (AKA RE/STOR)	Nebl, Inc.	1999-03-05
K974600	UROMED PATCH	Uromed Corp.	1998-03-31
K974645	FEMASSIST FLEXIBLE	Insight Medical Corp.	1998-02-12
K971359	RESTORE (A.K.A. CAPSURE)	Nebl, Inc.	1997-11-14
K963858	FEMASSIST URINARY DEVICE	Insight Medical Corp.	1997-10-21
K954215	MINIGUARD	Advanced Surgical Intervention, Inc.	1996-05-08

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