Semi-Automated Autologous Skin Graft Harvesting And Application Device
QYK is the FDA product code for Semi-Automated Autologous Skin Graft Harvesting And Application Device, a class II device type, regulated under 21 CFR 878.4795. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QYK
- Device name
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- FDA 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.
- Regulation
- 21 CFR 878.4795
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QYK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code QYK| Applicant | Clearances |
|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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