DeviceClearance

Product code QYM— General Hospital

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

Classification name
Ophthalmic Needle
Device class
Class 2
Regulation
21 CFR 880.5570
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QYM under 21 CFR 880.5570, via openFDA

Market context for product code QYM

FDA has cleared 2 devices under product code QYM between 2023 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QYM

Recent clearances under product code QYM

Data sourced from openFDA. This site is unofficial and independent of the FDA.