FDA product code HGE: Amniotome
HGE is the FDA product code for amniotome. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 6 510(k) submissions under HGE, from 6 different applicants. The average 510(k) review took 118 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Amniotome |
| Device class | Class I |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HGE clearance
Top HGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Onli | 1 | 1995-06-09 |
| Raymart Development Co. | 1 | 1994-03-07 |
| Epcom Medical Systems, Inc. | 1 | 1991-05-09 |
| Salt Creek Medical Technologies | 1 | 1987-03-23 |
| Go Medical Industries Pty. , Ltd. | 1 | 1985-04-15 |
1 more applicants have HGE clearances. See the full list in Caduvo.
Most recent HGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951148 | Onli | OBSTI-HOOK | 1995-06-09 | 88 |
| K926425 | Raymart Development Co. | AMNIPERF(TM) | 1994-03-07 | 439 |
| K910518 | Epcom Medical Systems, Inc. | GLOVE-N-GEL AMNIOTOMY KIT | 1991-05-09 | 92 |
| K871087 | Salt Creek Medical Technologies | S.C.M.T. PERFORATOR | 1987-03-23 | 5 |
| K850758 | Go Medical Industries Pty. , Ltd. | AMNIGLOVE & AMNICOT | 1985-04-15 | 49 |
Recalls for HGE devices
openFDA lists no recalls for product code HGE.
Frequently asked questions
What is FDA product code HGE?
HGE is the FDA product code for amniotome. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGE?
Class I, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HGE?
Across 6 cleared submissions the average was 118 days from receipt to decision (median 68).
Which companies have the most HGE clearances?
Onli (1); Raymart Development Co. (1); Epcom Medical Systems, Inc. (1); Salt Creek Medical Technologies (1); Go Medical Industries Pty. , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HGE
- Run a recall and safety report across every HGE manufacturer
- Watch product code HGE 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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