FDA product code NOC: Splint, Extremity, Non-Inflatable, External, Non-Sterile
NOC is the FDA product code for splint, extremity, non-inflatable, external, non-sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General and Plastic Surgery panel. Devices under NOC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NOC devices.
Definition
Non-inflatable extremity splint; See product code fyh.
Classification
| Field | Value |
|---|---|
| Device name | Splint, Extremity, Non-Inflatable, External, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 878.3910 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NOC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code NOC?
NOC is the FDA product code for splint, extremity, non-inflatable, external, non-sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General and Plastic Surgery panel.
What device class is NOC?
Class I, regulation 21 CFR 878.3910. Typical premarket route: 510(k) exempt.
Have NOC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code NOC
- Run a recall and safety report across every NOC manufacturer
- Watch product code NOC 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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