FDA product code HGF: Source, Abortion Unit, Vacuum
HGF is the FDA product code for source, 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 4 510(k) submissions under HGF, from 4 different applicants. The average 510(k) review took 77 days (median 89).
Classification
| Field | Value |
|---|---|
| Device name | Source, 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 HGF clearance
Top HGF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medgyn Products, Inc. | 1 | 1995-01-26 |
| Douglas James Donaldson Compliance Services | 1 | 1991-02-11 |
| Charles L. Rose and Co., Inc. | 1 | 1990-12-14 |
| Hgm Medical Laser Systems, Inc. | 1 | 1989-03-24 |
Most recent HGF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945179 | Medgyn Products, Inc. | BOTTLE COLLECTION SET | 1995-01-26 | 94 |
| K905115 | Douglas James Donaldson Compliance Services | BIOVISION ENDOCULAR PROBE | 1991-02-11 | 90 |
| K904248 | Charles L. Rose and Co., Inc. | MODEL GLASE 210 HOLMIUM LASER SYSTEM | 1990-12-14 | 88 |
| K890787 | Hgm Medical Laser Systems, Inc. | O-020 LASER INDIRECT OPHTHALMOSCOPE | 1989-03-24 | 37 |
Recalls for HGF devices
openFDA lists no recalls for product code HGF.
Frequently asked questions
What is FDA product code HGF?
HGF is the FDA product code for source, 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 HGF?
Class II, regulation 21 CFR 884.5070. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGF?
Across 4 cleared submissions the average was 77 days from receipt to decision (median 89).
Which companies have the most HGF clearances?
Medgyn Products, Inc. (1); Douglas James Donaldson Compliance Services (1); Charles L. Rose and Co., Inc. (1); Hgm Medical Laser Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HGF
- Run a recall and safety report across every HGF manufacturer
- Watch product code HGF 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times