FDA.reportPublic FDA data

510(k) K242073

Device
STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
Applicant
Tsk Laboratory International Japan KK
510(k) number
K242073
Product code
QYM
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-23
Date received
2024-07-16
Regulation
880.5570
Classification name
Ophthalmic Needle
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
Seika Shiba
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 QYM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.2023-10-18