Cleared Traditional

Arisure Closed System Drug Transfer Device (CSTD)

K201422 · Yukon Medical, LLC · General Hospital

Mar 2021

Decision

277d

Days

Class 2

Risk

About This 510(k) Submission

K201422 is an FDA 510(k) clearance for the Arisure Closed System Drug Transfer Device (CSTD), a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Yukon Medical, LLC (Durham, US). The FDA issued a Cleared decision on March 2, 2021, 277 days after receiving the submission on May 29, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K201422 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2020
Decision Date	March 02, 2021
Days to Decision	277 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting.