FDA product code HGZ: Heater, Perineal, Direct Contact
HGZ is the FDA product code for heater, perineal, direct contact. It is a Class II device, regulated under 21 CFR 884.5390 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HGZ. The average 510(k) review took 703 days (median 703).
Classification
| Field | Value |
|---|---|
| Device name | Heater, Perineal, Direct Contact |
| Device class | Class II |
| Regulation | 21 CFR 884.5390 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HGZ clearance
Top HGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Valleylab, Inc. | 1 | 1994-03-25 |
Most recent HGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921885 | Valleylab, Inc. | E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES | 1994-03-25 | 703 |
Recalls for HGZ devices
openFDA lists no recalls for product code HGZ.
Frequently asked questions
What is FDA product code HGZ?
HGZ is the FDA product code for heater, perineal, direct contact. It is a Class II device, regulated under 21 CFR 884.5390 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGZ?
Class II, regulation 21 CFR 884.5390. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HGZ?
Across 1 cleared submissions the average was 703 days from receipt to decision (median 703).
Which companies have the most HGZ clearances?
Valleylab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HGZ
- Run a recall and safety report across every HGZ manufacturer
- Watch product code HGZ 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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