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. and Tsk Laboratory International Japan KK.
FDA 510(k) Cleared Ophthalmic Needle Devices (Product Code QYM)
About Product Code QYM - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QYM since 2023, with 2 receiving FDA clearance (average review time: 148 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QYM have taken an average of 99 days to reach a decision - down from 197 days historically, suggesting improved FDA processing for this classification.
QYM devices are reviewed by the General Hospital panel. Browse all General Hospital devices →