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Immucise

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190427

by Terumo Corporation

Identifiers

510(k) Number
K190427 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Immucise Intradermal Injection System is a vertical-type intradermal (ID) injection device designed to administer vaccines and approved drugs directly into the dermal layer of the skin. This method is intended to enhance immune response compared to traditional intramuscular or subcutaneous injections. The device targets the deltoid region of the patient’s arm for precise delivery.

The system is supplied as a single-use, sterile device and is intended for use in general hospital settings. It adheres to FDA 510(k) clearance under the Traditional pathway, with a clearance number of K190427. No additional regulatory markings or MRI safety classifications are specified in the available data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Immucise™ Intradermal Injection System, Terumo Announces Commercial Launch of The Immucise™ Intradermal ..., Terumo Announces Commercial Launch of The Immucise™ Intradermal ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Terumo Corporation

Sources (1)

  • FDA 510(k) K190427 24 fields · synced Oct 1, 2026