FDA product code NOO: Clamp, Dialysis Arm
NOO is the FDA product code for clamp, dialysis arm. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under NOO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Dialysis Arm |
| Device class | Class I |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for NOO devices
openFDA lists no recalls for product code NOO.
Frequently asked questions
What is FDA product code NOO?
NOO is the FDA product code for clamp, dialysis arm. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is NOO?
Class I, regulation 21 CFR 876.5540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NOO
- Run a recall and safety report across every NOO manufacturer
- Watch product code NOO 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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