Femcap Cervical Contraceptive Cap
by Femcap Incorporated PMA
Active
PMA P020041
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP020041 | Date28 Mar 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Femcap Contraceptive Barrier Device
- Trade Name
- Femcap Barrier Contraceptive
- Generic Name
- Cap, cervical, contraceptive
- PMA Number
- FDA Product Code
- LLQ
- Device Class
- Class III
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Femcap Cervical Contraceptive Cap is a cervical barrier device classified as a Class III medical device under FDA regulations. It is designed to prevent or delay pregnancy by physically blocking sperm from entering the uterus through the cervix, serving as a non-hormonal contraceptive option for women of childbearing age.
This single-use, reusable device is supplied sterile and intended for vaginal insertion prior to intercourse. It is regulated under an FDA Premarket Approval (PMA) application (PMA Number: P020041) and falls under the product code LLQ for cervical barriers. Storage and handling must comply with sterile medical device protocols to ensure efficacy and safety.
Other devices from Femcap Incorporated
Questions
AI-generated answers, 18 Sep 2026
Is the Femcap designed for repeated use, or is it meant to be used only once and then discarded?
The Femcap is a **single-use, reusable** device. It is initially supplied sterile for first-time use, but it can be cleaned and reused by the same user after each menstrual cycle, provided proper sterilization and maintenance protocols are followed. This design allows for extended contraceptive use over time while maintaining sterility standards.
What sizes or models of the Femcap are available, and how do users determine the correct fit?
The Femcap is available in **two sizes** to accommodate different cervical anatomies. Users typically determine the correct size based on a cervical measurement performed by a healthcare provider. The manufacturer provides sizing tools or instructions to ensure proper fit, which is critical for effective contraception and comfort.
How should the Femcap be stored to maintain its sterility and functionality before first use?
The Femcap must be stored in a **sterile, sealed packaging** until first use. After opening, it should be handled with clean, dry hands or sterile applicators to prevent contamination. Storage conditions should comply with standard sterile medical device protocols, such as keeping it in a cool, dry place away from direct sunlight or moisture.
What is the intended user population for the Femcap, and how does it differ from hormonal contraceptives?
The Femcap is **indicated for women of childbearing age** who seek a **non-hormonal** contraceptive option. Unlike hormonal methods (e.g., birth control pills or patches), it works mechanically by physically blocking sperm from entering the uterus. This makes it suitable for users who prefer or require a method without hormonal intervention.