HDT · Device, Intrauterine, Contraceptive And Introducer
Obstetrics/Gynecology · 21 CFR 884.5360 · Class 3
Overview
| Product Code | HDT |
|---|---|
| Device Name | Device, Intrauterine, Contraceptive And Introducer |
| Regulation | 21 CFR 884.5360 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
| Implant | Yes |
Identification
A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is placed high in the uterine fundus with a string extending from the device through the cervical os into the vagina. This generic type of device includes the introducer, but does not include contraceptive IUD's that function by drug activity, which are subject to the new drug provisions of the Federal Food, Drug, and Cosmetic Act (see § 310.502).
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
