FDA product code KOY: Degreaser, Skin, Surgical
KOY is the FDA product code for degreaser, skin, surgical. It is a Class I device, regulated under 21 CFR 878.4730 and reviewed by the General and Plastic Surgery panel. Devices under KOY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 20 recalls for KOY devices.
Classification
| Field | Value |
|---|---|
| Device name | Degreaser, Skin, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4730 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for KOY devices
20 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-12-23.
| Year | Recalls |
|---|---|
| 2019 | 9 |
Frequently asked questions
What is FDA product code KOY?
KOY is the FDA product code for degreaser, skin, surgical. It is a Class I device, regulated under 21 CFR 878.4730 and reviewed by the General and Plastic Surgery panel.
What device class is KOY?
Class I, regulation 21 CFR 878.4730. Typical premarket route: 510(k) exempt.
Have KOY devices been recalled?
Yes: 20 product recalls across 6 recall events; the most recent began 2019-12-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KOY
- Run a recall and safety report across every KOY manufacturer
- Watch product code KOY 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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