Essure System
by Bayer Pharma AG PMA
Active
PMA P020014
Overview
The Essure System is a transcervical contraceptive tubal occlusion device classified as a Class III medical device. It is designed for permanent birth control by placing micro-inserts into the fallopian tubes, inducing fibrosis and blocking the passage of sperm to prevent pregnancy. The device is intended for use in women who have completed childbearing and wish to avoid surgical sterilization procedures. Its mechanism relies on tissue reaction and occlusion to achieve contraceptive effects.
The Essure System is supplied as a sterile, single-use device and is inserted through the cervix into the fallopian tubes under local anesthesia or conscious sedation. It is regulated under FDA PMA (Premarket Approval) with PMA number P020014 and product code HHS. The device was authorized for use following a review by the FDA’s Obstetrics/Gynecology advisory committee, with subsequent updates to labeling regarding nickel sensitivity. No active regulatory status is implied beyond the stated FDA_PMA authorization.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP020014 | Date4 Nov 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Transcervical contraceptive tubal occlusion device
- PMA Number
- FDA Product Code
- HHS
- Device Class
- Class III
- Regulation
- 21 CFR Part 884.5380
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- APPR Approved
Questions
What is the Essure System used for and who is it intended for?
The Essure System is designed for permanent birth control in women who have completed childbearing. It works by placing micro-inserts into the fallopian tubes, causing fibrosis and blocking sperm passage to prevent pregnancy. It is intended as an alternative to surgical sterilization procedures for those seeking non-invasive permanent contraception.
How is the Essure System supplied and is it reusable?
The Essure System is supplied as a sterile, single-use device. Each kit contains the micro-inserts and insertion tools meant for one procedure only, ensuring patient safety and sterility. Reuse is not recommended or intended.
What regulatory pathway was followed for the Essure System’s approval?
The Essure System was authorized through the FDA’s Premarket Approval (PMA) process, with PMA number P020014. It was reviewed by the FDA’s Obstetrics/Gynecology advisory committee, and subsequent updates addressed labeling concerns, including nickel sensitivity. The device is classified as a Class III medical device.
Are there any special considerations for storage or handling of the Essure System?
Since the Essure System is sterile and single-use, it should be stored according to manufacturer guidelines to maintain sterility until use. Proper handling ensures the integrity of the micro-inserts and tools, which are critical for successful placement during the procedure.