FDA product code ISM: Pylon, Post Surgical
ISM is the FDA product code for pylon, post surgical. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel. Devices under ISM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for ISM devices.
Classification
| Field | Value |
|---|---|
| Device name | Pylon, Post Surgical |
| Device class | Class I |
| Regulation | 21 CFR 890.3025 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for ISM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-10-25.
Frequently asked questions
What is FDA product code ISM?
ISM is the FDA product code for pylon, post surgical. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.
What device class is ISM?
Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.
Have ISM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-10-25.
Next steps
- Run an FDA pathway report with predicate devices for product code ISM
- Run a recall and safety report across every ISM manufacturer
- Watch product code ISM 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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