||external urethral occluder, urinary incontinence-control, female|
||Urological clamp for males.|
||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.
||Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.
||Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage.
||female urinary meatus
|Regulation Medical Specialty
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Urology and Lithotripsy Devices Branch (ULDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.|
|If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
- Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence
|Third Party Review
||Not Third Party Eligible