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510(k) K242956

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle by Ocuject, LLC — Product Code QNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2024
Date Received
September 25, 2024
Clearance Type
Special
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 Ocuject, LLC

  • K233343 — SteriCap Safety Needle; VitreJect Safety Needle (November 27, 2023)
  • K230959 — VitreJect® Needle; OcuSafe® Needle (September 14, 2023)
  • K230372 — VitreJect Syringe (September 8, 2023)
  • K212544 — MiniLoad Syringe (October 13, 2021)
  • K212805 — SteriCap Mini Needle and Standard Needles (September 30, 2021)
  • K202432 — MiniLoad Syringe (February 19, 2021)
  • K170768 — Mini Needle (July 10, 2017)

Other clearances for product code QNS

  • K231734 — STERiJECT Low Dead Space, STERiJECT The Invisible Needle (March 8, 2024)
  • K210444 — EZ-Injec LDV Sterile Safety Needle (February 16, 2021)