HDO · Valve, Tubal Occlusion
Obstetrics/Gynecology · 21 CFR 884.5380 · Class 3
Overview
| Product Code | HDO |
|---|---|
| Device Name | Valve, Tubal Occlusion |
| 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 (0 of 0)
No cleared devices on record.
