FDA product code HIM: Electrocautery, Endoscopic And Accessories
HIM is the FDA product code for electrocautery, endoscopic and accessories. It is a Class II device, regulated under 21 CFR 884.4100 and reviewed by the Obstetrics and Gynecology panel. Devices under HIM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Electrocautery, Endoscopic And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 884.4100 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Recalls for HIM devices
openFDA lists no recalls for product code HIM.
Frequently asked questions
What is FDA product code HIM?
HIM is the FDA product code for electrocautery, endoscopic and accessories. It is a Class II device, regulated under 21 CFR 884.4100 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIM?
Class II, regulation 21 CFR 884.4100. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HIM
- Run a recall and safety report across every HIM manufacturer
- Watch product code HIM 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times