De Novo
DEN210049: Medline ART Skin Harvesting System
FDA De Novo · medline industries, inc · decided Mar 27, 2024
Key facts
| De Novo number | DEN210049 |
|---|---|
| Device name | Medline ART Skin Harvesting System |
| Applicant | medline industries, inc |
| Product code | QYK |
| Date received | Oct 19, 2021 |
| Decision date | Mar 27, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 1417592 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: