FDA product code HDK: Scissors, Episiotomy
HDK is the FDA product code for scissors, episiotomy. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. Devices under HDK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Episiotomy |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for HDK devices
openFDA lists no recalls for product code HDK.
Frequently asked questions
What is FDA product code HDK?
HDK is the FDA product code for scissors, episiotomy. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDK?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HDK
- Run a recall and safety report across every HDK manufacturer
- Watch product code HDK 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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