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510(k) Data Aggregation
K Number
K042557Device Name
INNOJECT AUTO-INJECTOR
Manufacturer
Date Cleared
2004-11-08
(49 days)
Product Code
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
INNOJECT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Innoject auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and subcutaneous or intracavernosal injection of liquid drugs and biologics under the direction of a physician and according to approved drug or biologic labeling. The Innoject auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The Innoject auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
Device Description
The Innoject auto-injector consists of a syringe cartridge with prefixed needle, power pack housing with spring loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and a window tube with spring-loaded retraction mechanism. It is button actuated, and once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The Innoject auto-injector is individually packaged and ETO sterilized for single use.
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