FDA.reportPublic FDA data

510(k) K242956

Device
LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
Applicant
Ocuject, LLC
510(k) number
K242956
Product code
QNS
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-25
Date received
2024-09-25
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Leonid Lerner
Address
1441 Avocado Ave. Suite 204 Newport Beach CA US 92660 92660

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
K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK2024-03-08
K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc.2021-02-16