FDA product code HHO: Screw, Fibroid, Gynecological
HHO is the FDA product code for screw, fibroid, gynecological. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under HHO. The average 510(k) review took 170 days (median 170).
Classification
| Field | Value |
|---|---|
| Device name | Screw, Fibroid, Gynecological |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HHO clearance
Top HHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Urological, Inc. | 2 | 1992-05-18 |
Most recent HHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K915412 | Cook Urological, Inc. | HYSTEROSCOPIC MYOMA SCREW | 1992-05-18 | 168 |
| K915388 | Cook Urological, Inc. | LAPAROCOPIC MYOMA SCREW | 1992-05-18 | 171 |
Recalls for HHO devices
openFDA lists no recalls for product code HHO.
Frequently asked questions
What is FDA product code HHO?
HHO is the FDA product code for screw, fibroid, gynecological. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHO?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code HHO?
Across 2 cleared submissions the average was 170 days from receipt to decision (median 170).
Which companies have the most HHO clearances?
Cook Urological, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HHO
- Run a recall and safety report across every HHO manufacturer
- Watch product code HHO 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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