Medical Device Manufacturer · US , Durham , NC

Yukon Medical, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2012

Recent clearances: Arisure® Closed Male Luer with Spike Adapter (YM060), SmartSiteTM Vented Vial Access Device, Arisure Closed System Drug Transfer Device (CSTD)

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8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Yukon Medical, LLC General Hospital ✕

8 devices
1-8 of 8
Cleared Mar 21, 2025
Arisure® Closed Male Luer with Spike Adapter (YM060)
K240761 · LHI
General Hospital · 366d
Cleared Dec 06, 2024
SmartSiteTM Vented Vial Access Device
K243486 · LHI
General Hospital · 28d
Cleared Mar 02, 2021
Arisure Closed System Drug Transfer Device (CSTD)
K201422 · ONB
General Hospital · 277d
Cleared Jul 31, 2015
SmartSite Vented Vial Access Device
K151963 · LHI
General Hospital · 15d
Cleared Oct 04, 2013
SMARTSITE VIALSHIELD
K132863 · LHI
General Hospital · 22d
Cleared Aug 14, 2012
VIALOK SINGLE VIAL ACCESS DEVICE VENTED
K122265 · LHI
General Hospital · 15d
Cleared May 03, 2012
VIALOK NON-VENTED
K121182 · LHI
General Hospital · 15d
Cleared Mar 30, 2012
ARISURE NEUTRAL VALVE
K120799 · FPA
General Hospital · 14d
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