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510(k) K082587

AUTO-SAFETY INJECTOR-2 (ASI-2) by Medical House Products Limited — Product Code KZH

K082587 is an FDA 510(k) premarket notification submitted by Medical House Products Limited for the device "AUTO-SAFETY INJECTOR-2 (ASI-2)". The FDA issued a decision of Substantially Equivalent on October 2, 2008. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Medical House Products Limited has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2008
Date Received
September 8, 2008
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 by Medical House Products Limited

  • K060819 — COOL.CLICK 2 (June 16, 2006)

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)
  • K073476 — COMPACT AUTO-SAFETY INJECTOR (CASI) (March 7, 2008)
  • K062339 — DERMOTHERAP GUN (February 5, 2007)

FDA data resources