510(k) K010365
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2001
- Date Received
- February 7, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Urethral Occluder, Urinary Incontinence-Control, Female
- Device Class
- Class I
- Regulation Number
- 876.5160
- Review Panel
- GU
- Submission Type
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.