FDA.reportPublic FDA data

510(k) K231734

Device
STERiJECT Low Dead Space, STERiJECT The Invisible Needle
Applicant
Tsk Laboratory International Japan KK
510(k) number
K231734
Product code
QNS
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-08
Date received
2023-06-14
Regulation
880.5570
Classification name
Low Dead Space Needle, Single Lumen, Hypodermic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kana Ebina
Address
2-1-5 Hirayanagi-Cho Tochigi-Shi JP 328-0012 328-0012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC2024-10-25
K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc.2021-02-16