510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210049Unknown

Medline ART Skin Harvesting System

MEDLINE INDUSTRIES, LP - Northfield, Northfiled IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN210049 is the FDA 510(k) clearance record for Medline ART Skin Harvesting System, a class II device, cleared for Medline Industries, Inc. on under FDA product code QYK (Semi-Automated Autologous Skin Graft Harvesting And Application Device). FDA's definition for product code QYK 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...". FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming DEN210049.

Clearance record

Decision date
Received
(890 days to decision)
Product code
QYK Semi-Automated Autologous Skin Graft Harvesting And Application Device
Regulation
21 CFR 878.4795
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medline Industries, Inc. Three Lakes Dr., Northfiled IL
Third party review
No

Clearances, product code QYK

Trailing 12 months

FDA records hold no clearances under product code QYK in the trailing twelve months.

FDA records show no clearances under product code QYK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260