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KZH — Introducer, Syringe Needle Class II

FDA Device Classification

Classification Details

Product Code
KZH
Device Class
Class II
Regulation Number
880.6920
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243232synthon hispania s.lGripMateDecember 2, 2024
K213429emed technologies corporationAccuSert Needle InserterOctober 20, 2022
K163400ypsomedOrbit InserterJuly 26, 2017
K160860medtronic minimedMiniMed Quick-serterSeptember 22, 2016
K141384scandinavian health limitedWHISPERJECT AUTOINJECTORSeptember 12, 2014
K124026scandinavian health limitedLOBSTER AUTO-INJECTORSeptember 13, 2013
K122837owen mumfordAUTOJECT 2 FOR GLASSY SYRINGEOctober 15, 2012
K111467elcam medical acalFLEXI-Q DV AND DVR AUTO-INJECTORSFebruary 9, 2012
K082587medical house products limitedAUTO-SAFETY INJECTOR-2 (ASI-2)October 2, 2008
K073476medical house (asi) limitedCOMPACT AUTO-SAFETY INJECTOR (CASI)March 7, 2008
K062339dermoequiposDERMOTHERAP GUNFebruary 5, 2007
K063146disetronic medical systemsACCU-CHEK LINKASSISTNovember 27, 2006
K060141shl medical, usaDAI-RJune 12, 2006
K060389pharma-penCONFIDOSE IM AUTO-INJECTORJune 6, 2006
K051667indolorEZ-JECTSeptember 27, 2005
K050434shl medical, usaSHL DISPOSABLE AUTOINJECTORJune 24, 2005
K033696union medico apsPERSONAL INJECTORFebruary 16, 2005
K042557innojectINNOJECT AUTO-INJECTORNovember 8, 2004
K032848medsolve technologiesMEDSAFE SYSTEM INSERTERApril 12, 2004
K032425biogenINVISIJECT RESUSABLE AUTO-INJECTORNovember 5, 2003