FDA product code QML: Anal Fistula Closure Device
QML is the FDA product code for anal fistula closure device. It is a Class II device, regulated under 21 CFR 878.4835 and reviewed by the General and Plastic Surgery panel. Devices under QML reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device.
Classification
| Field | Value |
|---|---|
| Device name | Anal Fistula Closure Device |
| Device class | Class II |
| Regulation | 21 CFR 878.4835 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for QML devices
openFDA lists no recalls for product code QML.
Frequently asked questions
What is FDA product code QML?
QML is the FDA product code for anal fistula closure device. It is a Class II device, regulated under 21 CFR 878.4835 and reviewed by the General and Plastic Surgery panel.
What device class is QML?
Class II, regulation 21 CFR 878.4835. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QML
- Run a recall and safety report across every QML manufacturer
- Watch product code QML 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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