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510(k) K073476

COMPACT AUTO-SAFETY INJECTOR (CASI) by Medical House (Asi) Limited — Product Code KZH

K073476 is an FDA 510(k) premarket notification submitted by Medical House (Asi) Limited for the device "COMPACT AUTO-SAFETY INJECTOR (CASI)". The FDA issued a decision of Substantially Equivalent on March 7, 2008. 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
March 7, 2008
Date Received
December 10, 2007
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)
  • K062339 — DERMOTHERAP GUN (February 5, 2007)

FDA data resources