KNH · Laparoscopic Contraceptive Tubal Occlusion Device
Obstetrics/Gynecology · 21 CFR 884.5380 · Class 3
Overview
| Product Code | KNH |
|---|---|
| Device Name | Laparoscopic 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P070022 | ADIANA PERMANENT CONTRACEPTION SYSTEM | Hologic, Inc. | Jul 6, 2009 | APWD |
| P920046 | FILSHIE CLIP (MARK VI) SYSTEM | Femcare , Ltd. | Sep 5, 1996 | APPR |
| P870080 | HULKA CLIP FOR TUBAL OCCLUSION | Richard Wolf Medical Instruments Corp. | Sep 5, 1996 | APWD |
| P870076 | FALOPE RING BAND AND APPLICATOR SYSTEMS | Gyrus Acmi, Inc. | Sep 29, 1993 | APPR |
Top Applicants
- Femcare , Ltd. — 1 clearance
- Gyrus Acmi, Inc. — 1 clearance
- Hologic, Inc. — 1 clearance
- Richard Wolf Medical Instruments Corp. — 1 clearance
