FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Medline ART Skin Harvesting System
K Number: DEN210049
·
Decision Mar 27, 2024
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
238
Review Days
890
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Medline ART Skin Harvesting System
- K Number
- DEN210049
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 878.4795
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Medline Industries, Inc.
- Date Received
- October 19, 2021
- Decision Date
- March 27, 2024
- Product Code
- QYK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QYK | Semi-Automated Autologous Skin Graft Harvesting And Application Device | FDA class 2 | General, Plastic Surgery |
Other Clearances by Medline Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Oct 26, 2023 | Substantially Equivalent |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Jun 27, 2023 | Substantially Equivalent |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Jan 25, 2023 | Substantially Equivalent |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Dec 9, 2022 | Substantially Equivalent |
| K212911 | Konig Mogen Clamp | Nov 18, 2022 | Substantially Equivalent |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Oct 25, 2022 | Substantially Equivalent |
| K213481 | Medline General Surgery Tray | May 24, 2022 | Substantially Equivalent |
| K212093 | Medline Universal Grounding Pad | Jan 14, 2022 | Substantially Equivalent |
| K213068 | Medline Smoke Evacuation Shroud | Jan 3, 2022 | Substantially Equivalent |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Dec 10, 2021 | Substantially Equivalent |