Home / 510(k) Clearances / K901803

510(k) K901803

SYRINGE NEEDLE INTRODUCER by Glaxo, Inc. — Product Code KZH

K901803 is an FDA 510(k) premarket notification submitted by Glaxo, Inc. for the device "SYRINGE NEEDLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on November 20, 1990. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Glaxo, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1990
Date Received
April 19, 1990
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 Glaxo, Inc.

  • K954041 — G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVA (October 16, 1995)
  • K922187 — COMPACT SPACER (November 20, 1992)
  • K844169 — VOLUMATIC (November 9, 1984)

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