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510(k) K210444

EZ-Injec LDV Sterile Safety Needle by Poonglim Pharmatech, Inc. — Product Code QNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2021
Date Received
February 16, 2021
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 Poonglim Pharmatech, Inc.

  • K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volum (May 29, 2024)
  • K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volum (September 15, 2023)
  • K210443 — PLPT LDV (Low Dead Volume) Sterile Syringe (February 16, 2021)
  • K192222 — EZ-Inject Single use Needle (May 12, 2020)
  • K172483 — Kopac Sterile Needle (June 21, 2018)

Other clearances for product code QNS

  • K242956 — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Saf (October 25, 2024)
  • K231734 — STERiJECT Low Dead Space, STERiJECT The Invisible Needle (March 8, 2024)