Cleared Traditional

NEOSHIELD

K172499 · JMS North America Corporation · General Hospital

Jun 2018

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K172499 is an FDA 510(k) clearance for the NEOSHIELD, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by JMS North America Corporation (Hayward, US). The FDA issued a Cleared decision on June 1, 2018, 287 days after receiving the submission on August 18, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K172499 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2017
Decision Date	June 01, 2018
Days to Decision	287 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.