FALOPE RING BAND AND APPLICATOR SYSTEMS
Device Facts
| Record ID | P870076 |
|---|---|
| Device Name | FALOPE RING BAND AND APPLICATOR SYSTEMS |
| Applicant | Gyrus Acmi, Inc. |
| Product Code | KNH · Obstetrics/Gynecology |
| Decision Date | Sep 29, 1993 |
| Decision | APPR |
| Regulation | 21 CFR 884.5380 |
| Device Class | Class 3 |
Regulatory Classification
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.