Semi-Automated Autologous Skin Graft Harvesting And Application Device
The semi-automated autologous skin graft harvesting and application device (product code QYK) is a Class 2 General, Plastic Surgery handheld electromechanical surgical instrument (regulation 878.4795) that extracts autologous skin graft tissue from a healthy donor site and deposits it to a recipient site, with automated extraction and deposition functions activated by the user. Requiring 510(k) clearance, it is not intended for treatment of third-degree burns. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QYK
- Device Class
- FDA class 2
- Regulation Number
- 878.4795
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN210049 | Medline ART Skin Harvesting System | Mar 27, 2024 | Unknown | Medline Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.