FDA product code HFJ: Prosthesis, Fallopian Tube
HFJ is the FDA product code for prosthesis, fallopian tube. It is a Class II device, regulated under 21 CFR 884.3650 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HFJ. The average 510(k) review took 512 days (median 512).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Fallopian Tube |
| Device class | Class II |
| Regulation | 21 CFR 884.3650 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every HFJ clearance
Top HFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Ob/Gyn | 1 | 1994-09-27 |
Most recent HFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932114 | Cook Ob/Gyn | TUBAL LUMEN SUPPORT | 1994-09-27 | 512 |
Recalls for HFJ devices
openFDA lists no recalls for product code HFJ.
Frequently asked questions
What is FDA product code HFJ?
HFJ is the FDA product code for prosthesis, fallopian tube. It is a Class II device, regulated under 21 CFR 884.3650 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFJ?
Class II, regulation 21 CFR 884.3650. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFJ?
Across 1 cleared submissions the average was 512 days from receipt to decision (median 512).
Which companies have the most HFJ clearances?
Cook Ob/Gyn (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFJ
- Run a recall and safety report across every HFJ manufacturer
- Watch product code HFJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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