# Semi-Automated Autologous Skin Graft Harvesting And Application Device
> **Product code: QYK** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4795
## Classification
- **FDA Product Code:** QYK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4795
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QYK)
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