FDA product code HHJ: Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
HHJ is the FDA product code for locator, intracorporeal device, ultrasonic, obstetric-gynecologic. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HHJ. The average 510(k) review took 25 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic |
| Device class | Class II |
| Regulation | 21 CFR 884.2225 |
| 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 HHJ clearance
Top HHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ultraguide , Ltd. | 1 | 2002-10-22 |
Most recent HHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023227 | Ultraguide , Ltd. | USG 2000SA | 2002-10-22 | 25 |
Recalls for HHJ devices
openFDA lists no recalls for product code HHJ.
Frequently asked questions
What is FDA product code HHJ?
HHJ is the FDA product code for locator, intracorporeal device, ultrasonic, obstetric-gynecologic. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHJ?
Class II, regulation 21 CFR 884.2225. Typical premarket route: 510(k).
How long does a 510(k) take for product code HHJ?
Across 1 cleared submissions the average was 25 days from receipt to decision (median 25).
Which companies have the most HHJ clearances?
Ultraguide , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HHJ
- Run a recall and safety report across every HHJ manufacturer
- Watch product code HHJ 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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