FDA product code NVT: Tubing And Tubing/Filter Fits
NVT is the FDA product code for tubing and tubing/filter fits. It is a Class I device, regulated under 21 CFR 884.1700 and reviewed by the Obstetrics and Gynecology panel. Devices under NVT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NVT devices, 1 initiated in the last five years.
Definition
Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.
Classification
| Field | Value |
|---|---|
| Device name | Tubing And Tubing/Filter Fits |
| Device class | Class I |
| Regulation | 21 CFR 884.1700 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for NVT devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-10-21.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code NVT?
NVT is the FDA product code for tubing and tubing/filter fits. It is a Class I device, regulated under 21 CFR 884.1700 and reviewed by the Obstetrics and Gynecology panel.
What device class is NVT?
Class I, regulation 21 CFR 884.1700. Typical premarket route: 510(k) exempt.
Have NVT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code NVT
- Run a recall and safety report across every NVT manufacturer
- Watch product code NVT 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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