FDA product code HGH: Cannula, Suction, Uterine
HGH is the FDA product code for cannula, suction, uterine. It is a Class II device, regulated under 21 CFR 884.5070 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 6 510(k) submissions under HGH, from 6 different applicants. The average 510(k) review took 234 days (median 247).
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Suction, Uterine |
| 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 |
510(k) clearances per year for HGH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 269 |
| 2018 | 1 | 266 |
Compare with all 510(k) review times · Search every HGH clearance
Top HGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 1 | 2018-04-09 |
| Panpac Medical Corporation | 1 | 2017-01-13 |
| Dongguan Microview Medical Technology Co., Ltd. | 1 | 2015-03-25 |
| Womancare Global | 1 | 2010-03-04 |
| Kolster Methods | 1 | 1994-07-19 |
1 more applicants have HGH clearances. See the full list in Caduvo.
Most recent HGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172151 | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | Hysteroscopy System | 2018-04-09 | 266 |
| K161106 | Panpac Medical Corporation | PANPAC DISPOSABLE VACUUM CURETTES | 2017-01-13 | 269 |
| K140213 | Dongguan Microview Medical Technology Co., Ltd. | DISPOSABLE ENDOSCOPIC CANNULA | 2015-03-25 | 421 |
| K093508 | Womancare Global | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) | 2010-03-04 | 112 |
| K935820 | Kolster Methods | KOLSTER METHODS | 1994-07-19 | 228 |
Recalls for HGH devices
openFDA lists no recalls for product code HGH.
Frequently asked questions
What is FDA product code HGH?
HGH is the FDA product code for cannula, suction, uterine. It is a Class II device, regulated under 21 CFR 884.5070 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGH?
Class II, regulation 21 CFR 884.5070. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGH?
Across 6 cleared submissions the average was 234 days from receipt to decision (median 247).
Which companies have the most HGH clearances?
Chongquin Jinshan Science & Technology (Group) Co., Ltd. (1); Panpac Medical Corporation (1); Dongguan Microview Medical Technology Co., Ltd. (1); Womancare Global (1); Kolster Methods (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HGH
- Run a recall and safety report across every HGH manufacturer
- Watch product code HGH 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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