K Number
K962017Device Name
HYPODERMIC JET INJECTION APPARATUSManufacturer
Date Cleared
1996-07-26
(64 days)
Product Code
Regulation Number
872.4475Type
TraditionalPanel
DEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 872.4475 Spring-powered jet injector.
(a)
Identification. A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.(b)
Classification. Class II.