Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Immucise Intradermal Injection System

K-Number: K181369 · 2018-11-13

ApplicantTerumo Corporation
Decision Date2018-11-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Immucise Intradermal Injection System is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2018-11-13 under 510(k) number K181369. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Immucise Intradermal Injection System?

Immucise Intradermal Injection System is a medical device that received FDA 510(k) clearance on 2018-11-13. The listed applicant is Terumo Corporation. The 510(k) number is K181369.

When did Immucise Intradermal Injection System receive FDA 510(k) clearance?

Immucise Intradermal Injection System received FDA 510(k) clearance on 2018-11-13, under 510(k) number K181369.

Who is the listed applicant for Immucise Intradermal Injection System?

The FDA 510(k) record lists Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immucise Intradermal Injection System?

The FDA product code for Immucise Intradermal Injection System is FMI.

Other records listing Terumo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252295RyureiK250700Pen Injector Needle 32.5K250751DualView CatheterK240818R2P Radifocus Glidewire AdvantageK240859Glidewire GT-RK190427Immucise

View all 9 devices →

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑