HFJ · Prosthesis, Fallopian Tube
Obstetrics/Gynecology · 21 CFR 884.3650 · Class 2
Overview
| Product Code | HFJ |
|---|---|
| Device Name | Prosthesis, Fallopian Tube |
| Regulation | 21 CFR 884.3650 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| Implant | Yes |
Identification
A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932114 | TUBAL LUMEN SUPPORT | Cook Ob/Gyn | Sep 27, 1994 | SESE |
Top Applicants
- Cook Ob/Gyn — 1 clearance
