FDA product code HGG: Controller, Abortion Unit, Vacuum
HGG is the FDA product code for controller, abortion unit, vacuum. It is a Class II device, regulated under 21 CFR 884.5070 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HGG. The average 510(k) review took 75 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Controller, Abortion Unit, Vacuum |
| Device class | Class II |
| Regulation | 21 CFR 884.5070 |
| 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 HGG clearance
Top HGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Galenica Enterprises, Inc. | 1 | 1988-10-18 |
Most recent HGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883283 | Galenica Enterprises, Inc. | DISPOSABLE AMNIOTOME | 1988-10-18 | 75 |
Recalls for HGG devices
openFDA lists no recalls for product code HGG.
Frequently asked questions
What is FDA product code HGG?
HGG is the FDA product code for controller, abortion unit, vacuum. It is a Class II device, regulated under 21 CFR 884.5070 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGG?
Class II, regulation 21 CFR 884.5070. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGG?
Across 1 cleared submissions the average was 75 days from receipt to decision (median 75).
Which companies have the most HGG clearances?
Galenica Enterprises, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HGG
- Run a recall and safety report across every HGG manufacturer
- Watch product code HGG 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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