FDA product code ISN: Cable
ISN is the FDA product code for cable. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. Devices under ISN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cable |
| Device class | Class I |
| Regulation | 21 CFR 890.3420 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for ISN devices
openFDA lists no recalls for product code ISN.
Frequently asked questions
What is FDA product code ISN?
ISN is the FDA product code for cable. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is ISN?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code ISN
- Run a recall and safety report across every ISN manufacturer
- Watch product code ISN 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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