Cleared Traditional

Immucise Intradermal Injection System

K181369 · Terumo Corporation · General Hospital

Nov 2018

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K181369 is an FDA 510(k) clearance for the Immucise Intradermal Injection System, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Terumo Corporation (Shibuya-Ku, JP). The FDA issued a Cleared decision on November 13, 2018, 174 days after receiving the submission on May 23, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K181369 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2018
Decision Date	November 13, 2018
Days to Decision	174 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF