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510(k) K161906

SCIg60 Infuser by Emed Technologies Corporation — Product Code PKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2016
Date Received
July 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoglobulin G (Igg) Infusion System
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.

Other clearances by Emed Technologies Corporation

  • K251105 — Tetra (TM-20); Tetra (TM-50) (December 22, 2025)
  • K240148 — SCIg60 Infusion System (February 16, 2024)
  • K230883 — VersaPump Infusion System (November 28, 2023)
  • K213429 — AccuSert Needle Inserter (October 20, 2022)
  • K222087 — SCIg60 Infusion System (October 13, 2022)
  • K173783 — SCIg60 Infusion System (December 14, 2018)
  • 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 PKP

  • K251105 — Tetra (TM-20); Tetra (TM-50) (December 22, 2025)
  • K240148 — SCIg60 Infusion System (February 16, 2024)
  • K230883 — VersaPump Infusion System (November 28, 2023)
  • K222087 — SCIg60 Infusion System (October 13, 2022)
  • K173783 — SCIg60 Infusion System (December 14, 2018)
  • K142319 — SCIg60 Infuser, Infuset (May 14, 2015)