FDA product code HDG: Speculum, Vaginal, Metal, Fiberoptic
HDG is the FDA product code for speculum, vaginal, metal, fiberoptic. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under HDG, from 2 different applicants. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Speculum, Vaginal, Metal, Fiberoptic |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HDG clearance
Top HDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luxtec Corp. | 1 | 1987-01-09 |
| Welch Allyn, Inc. | 1 | 1977-07-14 |
Most recent HDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864865 | Luxtec Corp. | SPECULUM, VAGINAL, METAL FIBEROPTIC | 1987-01-09 | 29 |
| K771181 | Welch Allyn, Inc. | VAGINAL ILLUMINATOR, MODEL 78570 | 1977-07-14 | 14 |
Recalls for HDG devices
openFDA lists no recalls for product code HDG.
Frequently asked questions
What is FDA product code HDG?
HDG is the FDA product code for speculum, vaginal, metal, fiberoptic. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDG?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HDG?
Across 2 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most HDG clearances?
Luxtec Corp. (1); Welch Allyn, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HDG
- Run a recall and safety report across every HDG manufacturer
- Watch product code HDG 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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