HHS · Transcervical Contraceptive Tubal Occlusion Device
Obstetrics/Gynecology · 21 CFR 884.5380 · Class 3
Overview
| Product Code | HHS |
|---|---|
| Device Name | Transcervical Contraceptive Tubal Occlusion Device |
| Regulation | 21 CFR 884.5380 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
| Implant | Yes |
Identification
A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P020014 | ESSURE SYSTEM | Bayer Pharma AG | Nov 4, 2002 | APPR |
Top Applicants
- Bayer Pharma AG — 1 clearance
