Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4795](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4795) → QYK — Semi-Automated Autologous Skin Graft Harvesting And Application Device

# QYK · Semi-Automated Autologous Skin Graft Harvesting And Application Device

_General, Plastic Surgery · 21 CFR 878.4795 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QYK

## Overview

- **Product Code:** QYK
- **Device Name:** Semi-Automated Autologous Skin Graft Harvesting And Application Device
- **Regulation:** [21 CFR 878.4795](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4795)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN210049](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QYK/DEN210049.md) | Medline ART Skin Harvesting System | Medline Industries, Inc. | Mar 27, 2024 | DENG |

## Top Applicants

- Medline Industries, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QYK](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QYK)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com