FDA product code NNY: Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
NNY is the FDA product code for sheath, corrugated rubber, for non-indwelling catheter, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. Devices under NNY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for NNY devices.
Definition
Urine collector and accessories; see product code EYT.
Classification
| Field | Value |
|---|---|
| Device name | Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNY devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-02-27.
| Year | Recalls |
|---|---|
| 2019 | 2 |
Frequently asked questions
What is FDA product code NNY?
NNY is the FDA product code for sheath, corrugated rubber, for non-indwelling catheter, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is NNY?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
Have NNY devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2019-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NNY
- Run a recall and safety report across every NNY manufacturer
- Watch product code NNY 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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