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510(k) K872233

INJECT-EASE by Palco Laboratories, Inc. — Product Code KZH

K872233 is an FDA 510(k) premarket notification submitted by Palco Laboratories, Inc. for the device "INJECT-EASE". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Palco Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
June 10, 1987
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 Palco Laboratories, Inc.

  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K943842 — PULSE OXIMETER MODEL 305 (March 24, 1995)
  • K920066 — PALCO LABS MODEL 340 PULSE OXIMETER (March 16, 1993)
  • K913694 — PALCO LABS LOADMATIC (December 17, 1991)
  • K911191 — PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR (June 10, 1991)
  • K904988 — PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR (March 18, 1991)
  • K842547 — WET-STOP (October 19, 1984)
  • K833344 — AUTO-LANCET (November 7, 1983)

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