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510(k) K213429

AccuSert Needle Inserter by Emed Technologies Corporation — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2022
Date Received
October 21, 2021
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

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  • K222087 — SCIg60 Infusion System (October 13, 2022)
  • K173783 — SCIg60 Infusion System (December 14, 2018)
  • K161906 — SCIg60 Infuser (December 1, 2016)
  • K142319 — SCIg60 Infuser, Infuset (May 14, 2015)
  • K140133 — INFUSET FLOW CONTROL EXTENSION SET (May 15, 2014)
  • K140131 — SUB-Q SUBCUTANEOUS TISSUE INFUSION SET (April 3, 2014)
  • K123729 — VERSARATE FLOW RATE CONTROLER (December 21, 2012)

Other clearances for product code KZH

  • K243232 — GripMate (December 2, 2024)
  • 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)
  • K062339 — DERMOTHERAP GUN (February 5, 2007)