Identity
- Trade Name
- FEMSOFT URETHRAL INSERT FDA PMA
- Generic Name
- Transurethral occlusion insert, urinary incontinence-control, female FDA PMA
Identifiers
- PMA Number
- P990002 FDA PMA
- FDA Product Code
- OCK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APWD FDA PMA
The Femsoft Urethral Insert is a transurethral occlusion device designed for the management of stress urinary incontinence in adult females. Classified as a transurethral occlusion insert, it functions by occluding the urethra to prevent involuntary urine leakage during physical exertion or activities that increase abdominal pressure.
This device is supplied as a single-use, sterile product and is regulated under an FDA Premarket Approval (PMA) with PMA number P990002. It is intended for use in clinical settings by healthcare professionals and must be handled according to sterile procedures. The device is categorized under product code OCK and is intended for female patients only, as specified in its regulatory submission.
Frequently asked questions
What is the Femsoft Urethral Insert used for in clinical practice?
The Femsoft Urethral Insert is designed specifically to manage stress urinary incontinence in adult females. It works by occluding the urethra, which helps prevent involuntary urine leakage during activities like exercise or coughing that increase abdominal pressure. It is intended for use only in clinical settings by healthcare professionals.
Is the Femsoft Urethral Insert intended for single-use or reusable applications?
The Femsoft Urethral Insert is supplied as a single-use, sterile product. This means it is meant to be used once per patient and then discarded, ensuring patient safety and reducing the risk of infection. Sterile handling procedures must be followed during use.
How is the regulatory approval status of the Femsoft Urethral Insert determined?
The Femsoft Urethral Insert holds an FDA Premarket Approval (PMA) with the approval number P990002. This approval was granted after a thorough review process, including a decision made by the Gastroenterology and Urology advisory committee (GU) in 1999. The device is classified under product code OCK and is regulated as a Class III medical device.
What types of storage conditions should be followed for the Femsoft Urethral Insert?
While the exact storage conditions are not detailed in the provided data, the device is supplied as sterile and single-use. Typically, sterile medical devices like this should be stored in a clean, dry environment, protected from contamination, and within the manufacturer’s recommended temperature range (often room temperature) until use. Always refer to the manufacturer’s instructions for precise storage guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990002 | Class III | Active |
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Manufacturer
- Manufacturer
- Rochester Medical Corp.
Sources (1)
- FDA PMA P990002 24 fields · synced Sep 18, 2026