FDA product code NWW: Hysteroscope Accessories
NWW is the FDA product code for hysteroscope accessories. It is a Class I device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel. Devices under NWW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
Classification
| Field | Value |
|---|---|
| Device name | Hysteroscope Accessories |
| Device class | Class I |
| Regulation | 21 CFR 884.1690 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for NWW devices
openFDA lists no recalls for product code NWW.
Frequently asked questions
What is FDA product code NWW?
NWW is the FDA product code for hysteroscope accessories. It is a Class I device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel.
What device class is NWW?
Class I, regulation 21 CFR 884.1690. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NWW
- Run a recall and safety report across every NWW manufacturer
- Watch product code NWW 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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