510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QYMClass II

Ophthalmic Needle

21 CFR 880.5570 / General Hospital
FDA source (opens on fda.gov)

QYM is the FDA product code for Ophthalmic Needle, a class II device type, regulated under 21 CFR 880.5570. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QYM
Device name
Ophthalmic Needle
FDA 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.
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QYM

By decision year
2 clearances under product code QYM with a decision year between 2023 and 2024, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QYM by decision year
YearClearances
20231
20241

Applicants with the most clearances

Product code QYM
Applicants holding the most 510(k) clearances under product code QYM
ApplicantClearances
Terumo Europe N.V.1
TSK Laboratory International Japan KK1

Companies listing this code with FDA

Companies whose registered establishments list this code