Home / 510(k) Clearances / K033696

510(k) K033696

PERSONAL INJECTOR by Union Medico Aps — Product Code KZH

K033696 is an FDA 510(k) premarket notification submitted by Union Medico Aps for the device "PERSONAL INJECTOR". The FDA issued a decision of Substantially Equivalent on February 16, 2005. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2005
Date Received
November 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Syringe Needle
Device Class
Class II
Regulation Number
880.6920
Review Panel
HO
Submission Type

Other clearances for product code KZH

  • K243232 — GripMate (December 2, 2024)
  • K213429 — AccuSert Needle Inserter (October 20, 2022)
  • K163400 — Orbit Inserter (July 26, 2017)
  • K160860 — MiniMed Quick-serter (September 22, 2016)
  • K141384 — WHISPERJECT AUTOINJECTOR (September 12, 2014)
  • K124026 — LOBSTER AUTO-INJECTOR (September 13, 2013)
  • K122837 — AUTOJECT 2 FOR GLASSY SYRINGE (October 15, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K082587 — AUTO-SAFETY INJECTOR-2 (ASI-2) (October 2, 2008)
  • K073476 — COMPACT AUTO-SAFETY INJECTOR (CASI) (March 7, 2008)

FDA data resources