FDA Product Code QYM: Ophthalmic Needle
An Ophthalmic Needle Is A Needle Intended For Intraocular Injections. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye.
Leading manufacturers include Terumo Europe N.V., Tsk Laboratory International Japan KK and Tsk Laboratory, Japan.
3
Total
3
Cleared
124d
Avg days
2023
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
77d
recently vs 148d historically
FDA 510(k) Cleared Ophthalmic Needle Devices (Product Code QYM)
3 devices
Cleared
Oct 06, 2026
TSK OptiXion
Tsk Laboratory, Japan
General Hospital
77d
Cleared
Oct 23, 2024
STERiJECT Ophthalmic Needle
Tsk Laboratory International Japan KK
General Hospital
99d
Cleared
Oct 18, 2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
Terumo Europe N.V.
General Hospital
197d
About Product Code QYM - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QYM since 2023, with 3 receiving FDA clearance (average review time: 124 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - QYM Product Code
Recent submissions under QYM have taken an average of 77 days to reach a decision - down from 148 days historically, suggesting improved FDA processing for this classification.
QYM devices are reviewed by the General Hospital panel. Browse all General Hospital devices →