21 CFR 884.5380 — Valve, Tubal Occlusion
Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5380
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HDO | Valve, Tubal Occlusion | 3 | 0 | Implant |
| HFY | Band, Tubal Occlusion | 3 | 0 | Implant |
| HGB | Clip, Tubal Occlusion | 3 | 0 | Implant |
| HHS | Transcervical Contraceptive Tubal Occlusion Device | 3 | 1 | Implant |
| KNH | Laparoscopic Contraceptive Tubal Occlusion Device | 3 | 4 | Implant |
