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510(k) K231734

STERiJECT Low Dead Space, STERiJECT The Invisible Needle by Tsk Laboratory International Japan KK — Product Code QNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2024
Date Received
June 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Low Dead Space Needle, Single Lumen, Hypodermic
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.

Other clearances by Tsk Laboratory International Japan KK

  • K242073 — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (October 23, 2024)

Other clearances for product code QNS

  • K242956 — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Saf (October 25, 2024)
  • K210444 — EZ-Injec LDV Sterile Safety Needle (February 16, 2021)