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510(k) K042557

INNOJECT AUTO-INJECTOR by Innoject, Inc. — Product Code KZH

K042557 is an FDA 510(k) premarket notification submitted by Innoject, Inc. for the device "INNOJECT AUTO-INJECTOR". The FDA issued a decision of Substantially Equivalent on November 8, 2004. 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
November 8, 2004
Date Received
September 20, 2004
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